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More About 510(k)
510K Number
Type
Traditional
Special
Abbreviated
Cleared for Marketing Automatic Class III Designation
Model
Cleared/Approved IVD Products
Applicant Name
Expedited Review
Yes
No
No Data
Device Name
Third Party Reviewed
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Product Code
Decision
CLEARED FOR MARKETING AUTOMATIC CLASS III DESIGNAT (AN)
SE SUBJECT TO TRACKING REG (ST)
SE SUBJECT TO TRAKING & PMS (PT)
SE WAITING ON FUTURE POLICIES (SF)
SE-SPECIAL LABELING (SS)
SUBST EQUIV (SE)
SUBST EQUIV - AWAITING DEVICE APPROVA (SA)
SUBST EQUIV - AWAITING DRUG APPROVAL (SW)
SUBST EQUIV - CLIA SUBMISSION (CS)
SUBST EQUIV - KIT (SK)
SUBST EQUIV - KIT WITH DRUGS (KD)
SUBST EQUIV - MARKET AFTER INSPECTION (SI)
SUBST EQUIV - POSTMARKET SURVEILLANCE (SP)
SUBST EQUIV - WITH LIMITATIONS (SU)
SUBST EQUIV FOR SOME INDICATIONS (SN)
SUBST EQUIV WITH DRUG (SD)
Decision Date
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