510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162282Substantially Equivalent

CardioChek Plus Test System, CardioChek Home Test System

Polymer Technology Systems, Inc. D/B/A Pts Diagnostics, Indianapolis IN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162282 is the FDA 510(k) clearance record for CardioChek Plus Test System, CardioChek Home Test System, a class II device, cleared for Polymer Technology Systems, Inc. D/B/A Pts Diagnostics on under FDA product code CGA (Glucose Oxidase, Glucose). FDA records list 3 510(k) clearances for Polymer Technology Systems, Inc. D/B/A Pts Diagnostics, from to . As of , FDA records show 2 recalls naming K162282.

Clearance record

Decision date
Received
(129 days to decision)
Product code
CGA Glucose Oxidase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Polymer Technology Systems, Inc. D/B/A Pts Diagnostics 7736 Zionsville Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CGA

Trailing 12 months
1 clearance under product code CGA in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CGA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260