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
K991010Substantially Equivalent

Acp

Abbott Diagnostics Mfg., Inc., Irving TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991010 is the FDA 510(k) clearance record for ACP, a class II device, cleared for Abbott Diagnostics Mfg., Inc. on under FDA product code CKB (Acid Phosphatase, Naphthyl Phosphate). FDA records list one 510(k) clearance for Abbott Diagnostics Mfg., Inc. As of , FDA records show no recalls naming K991010.

Clearance record

Decision date
Received
(54 days to decision)
Product code
CKB Acid Phosphatase, Naphthyl Phosphate
Regulation
21 CFR 862.1020
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Abbott Diagnostics Mfg., Inc. 1920 Hurd Dr., Irving TX
510(k) summary
Summary
Third party review
No

Clearances, product code CKB

Trailing 12 months

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

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