510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K842151Substantially Equivalent

Chlamydiae Immunoperoxidase Test Kit

Bartels Immunodiagnostic Supplies, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842151 is the FDA 510(k) clearance record for CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT, a class I device, cleared for Bartels Immunodiagnostic Supplies, Inc. on under FDA product code LKH (Antisera, Immunoperoxidase, Chlamydia Spp.). FDA records list 35 510(k) clearances for Bartels Immunodiagnostic Supplies, Inc., from to . As of , FDA records show no recalls naming K842151.

Clearance record

Decision date
Received
(51 days to decision)
Product code
LKH Antisera, Immunoperoxidase, Chlamydia Spp.
Regulation
21 CFR 866.3120
Device class
Class I
Review panel
Microbiology
Applicant
Bartels Immunodiagnostic Supplies, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code LKH

Trailing 12 months

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

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