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
K760032Substantially Equivalent

Test, Mono., Differential Slide

Gamma Biologicals, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K760032 is the FDA 510(k) clearance record for TEST, MONO., DIFFERENTIAL SLIDE, a class I device, cleared for Gamma Biologicals, Inc. on under FDA product code KIN (Slide Stainer, Contact Type). FDA records list 21 510(k) clearances for Gamma Biologicals, Inc., from to . As of , FDA records show no recalls naming K760032.

Clearance record

Decision date
Received
(50 days to decision)
Product code
KIN Slide Stainer, Contact Type
Regulation
21 CFR 864.3800
Device class
Class I
Review panel
Pathology
Applicant
Gamma Biologicals, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KIN

Trailing 12 months

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

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