510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851275Substantially Equivalent

Gibco Mycotect 189-5670

Gibco Laboratories Life Technologies, Inc., Grandisland NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851275 is the FDA 510(k) clearance record for GIBCO MYCOTECT 189-5670, a class I device, cleared for Gibco Laboratories Life Technologies, Inc. on under FDA product code KIW (Kit, Mycoplasma Detection). FDA records list 67 510(k) clearances for Gibco Laboratories Life Technologies, Inc., from to . As of , FDA records show no recalls naming K851275.

Clearance record

Decision date
Received
(81 days to decision)
Product code
KIW Kit, Mycoplasma Detection
Regulation
21 CFR 864.2360
Device class
Class I
Review panel
Hematology
Applicant
Gibco Laboratories Life Technologies, Inc. P.O. Box 68, Grandisland NY
Third party review
No

Clearances, product code KIW

Trailing 12 months

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

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