510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K893885Substantially Equivalent

Bacton Tm, Basic Tm, Apo a-I Reagent

Catachem, Inc., Bridgeport CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893885 is the FDA 510(k) clearance record for BACTON TM, BASIC TM, APO A-I REAGENT, a class I device, cleared for Catachem, Inc. on under FDA product code DEL (Lipoprotein X, Antigen, Antiserum, Control). FDA records list 41 510(k) clearances for Catachem, Inc., from to . As of , FDA records show no recalls naming K893885.

Clearance record

Decision date
Received
(22 days to decision)
Product code
DEL Lipoprotein X, Antigen, Antiserum, Control
Regulation
21 CFR 866.5590
Device class
Class I
Review panel
Immunology
Applicant
Catachem, Inc. 955 Connecticut Ave., Bridgeport CT
Third party review
No

Clearances, product code DEL

Trailing 12 months

FDA records hold no clearances under product code DEL in the trailing twelve months.

FDA records show no clearances under product code DEL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DEL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260