510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K870042Substantially Equivalent

Assera-Plate Protein S Kit

American Bioproducts Co., Parsippany NJ / Traditional, Substantially Equivalent

K870042 is the FDA 510(k) clearance record for ASSERA-PLATE PROTEIN S KIT, cleared for American Bioproducts Co. on . FDA records list 79 510(k) clearances for American Bioproducts Co., from to . As of , FDA records show no recalls naming K870042.

Clearance record

Decision date
Received
(39 days to decision)
Review panel
Unknown
Applicant
American Bioproducts Co. 601 N. Jefferson Rd., Parsippany NJ
Third party review
No