510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K832267Substantially Equivalent

Fitc Goat Anti-Human Lamba

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

K832267 is the FDA 510(k) clearance record for FITC GOAT ANTI-HUMAN LAMBA, a class II device, cleared for Gelco Diagnostics, Inc. on under FDA product code DES (Lambda, Fitc, Antigen, Antiserum, Control). FDA records list 14 510(k) clearances for Gelco Diagnostics, Inc., from to . As of , FDA records show no recalls naming K832267.

Clearance record

Decision date
Received
(123 days to decision)
Product code
DES Lambda, Fitc, Antigen, Antiserum, Control
Regulation
21 CFR 866.5550
Device class
Class II
Review panel
Immunology
Applicant
Gelco Diagnostics, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code DES

Trailing 12 months

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

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