510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K040693Substantially Equivalent

Pts Panels Ldl Cholesterol Test Strips

Polymer Technology Systems, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040693 is the FDA 510(k) clearance record for PTS PANELS LDL CHOLESTEROL TEST STRIPS, a class I device, cleared for Polymer Technology Systems, Inc. on under FDA product code MRR (System, Test, Low Density, Lipoprotein). FDA records list 27 510(k) clearances for Polymer Technology Systems, Inc., from to . As of , FDA records show one recall naming K040693.

Clearance record

Decision date
Received
(111 days to decision)
Product code
MRR System, Test, Low Density, Lipoprotein
Regulation
21 CFR 862.1475
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Polymer Technology Systems, Inc. 7736 Zionsville Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MRR

Trailing 12 months

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

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