510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K850638Substantially Equivalent

Laser Apo a-I Test Apolipoprotein a-I Reagents

Behring Diagnostics, Inc., La Jolla CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850638 is the FDA 510(k) clearance record for LASER APO A-I TEST APOLIPOPROTEIN A-I REAGENTS, a class I device, cleared for Behring Diagnostics, Inc. on under FDA product code MSJ (Apolipoproteins). FDA records list 145 510(k) clearances for Behring Diagnostics, Inc., from to . As of , FDA records show no recalls naming K850638.

Clearance record

Decision date
Received
(85 days to decision)
Product code
MSJ Apolipoproteins
Regulation
21 CFR 862.1475
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Behring Diagnostics, Inc. 10933 No Torrey Pines Rd., La Jolla CA
Third party review
No

Clearances, product code MSJ

Trailing 12 months

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

FDA records show no clearances under product code MSJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MSJ, 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