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
K991111Substantially Equivalent

Buffer Chromogen (R1), Product No. Ca110-01, Edta Reagen (R2), Product No. Ca110-02

A.P. Total Care, Inc., Bridgeport CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991111 is the FDA 510(k) clearance record for BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02, a class II device, cleared for A.P. Total Care, Inc. on under FDA product code CIC (Cresolphthalein Complexone, Calcium). FDA records list 18 510(k) clearances for A.P. Total Care, Inc., from to . As of , FDA records show no recalls naming K991111.

Clearance record

Decision date
Received
(54 days to decision)
Product code
CIC Cresolphthalein Complexone, Calcium
Regulation
21 CFR 862.1145
Device class
Class II
Review panel
Clinical Chemistry
Applicant
A.P. Total Care, Inc. 70 Hawley Ave.,, Bridgeport CT
510(k) summary
Statement
Third party review
No

Clearances, product code CIC

Trailing 12 months

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

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