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
K152679Substantially Equivalent

Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak

Bio-Rad Laboratories Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K152679 is the FDA 510(k) clearance record for Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak, a class II device, cleared for Bio-Rad Laboratories on under FDA product code PMN (Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays). FDA's definition for product code PMN reads: "Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use". FDA records list 128 510(k) clearances for Bio-Rad Laboratories, from to . As of , FDA records show no recalls naming K152679.

Clearance record

Decision date
Received
(235 days to decision)
Product code
PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Regulation
21 CFR 866.3920
Device class
Class II
Review panel
Microbiology
Applicant
Bio-Rad Laboratories 9500 Jeronimo Rd., Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PMN

Trailing 12 months
5 clearances under product code PMN in the twelve months to October 2026, March 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code PMN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20263
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260