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
K820647Substantially Equivalent

Gamma Fetal Bleed Screening Test

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

K820647 is the FDA 510(k) clearance record for GAMMA FETAL BLEED SCREENING TEST, a class II device, cleared for Gamma Biologicals, Inc. on under FDA product code LIM (Test, Screening, For D Positive Fetal Rbc'S). FDA records list 21 510(k) clearances for Gamma Biologicals, Inc., from to . As of , FDA records show no recalls naming K820647.

Clearance record

Decision date
Received
(64 days to decision)
Product code
LIM Test, Screening, For D Positive Fetal Rbc'S
Regulation
21 CFR 864.7455
Device class
Class II
Review panel
Hematology
Applicant
Gamma Biologicals, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code LIM

Trailing 12 months

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

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