510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963911Substantially Equivalent

Alpco/mercodia Insulin Elisa

American Laboratory Products Company, Windham NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963911 is the FDA 510(k) clearance record for ALPCO/MERCODIA INSULIN ELISA, a class I device, cleared for American Laboratory Products Co., Ltd. on under FDA product code CFP (Radioimmunoassay, Immunoreactive Insulin). FDA records list 27 510(k) clearances for American Laboratory Products Co., Ltd., from to . As of , FDA records show no recalls naming K963911.

Clearance record

Decision date
Received
(32 days to decision)
Product code
CFP Radioimmunoassay, Immunoreactive Insulin
Regulation
21 CFR 862.1405
Device class
Class I
Review panel
Clinical Chemistry
Applicant
American Laboratory Products Co., Ltd. 87 Indian Rock Rd., Windham NH
510(k) summary
Statement
Third party review
No

Clearances, product code CFP

Trailing 12 months

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

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