510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981865Substantially Equivalent

Mtm Bioscanner K Test Strips

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

K981865 is the FDA 510(k) clearance record for MTM BIOSCANNER K TEST STRIPS, a class I device, cleared for Polymer Technology Systems, Inc. on under FDA product code JMK (Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase). FDA records list 27 510(k) clearances for Polymer Technology Systems, Inc., from to . As of , FDA records show no recalls naming K981865.

Clearance record

Decision date
Received
(274 days to decision)
Product code
JMK Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
Regulation
21 CFR 862.1380
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Polymer Technology Systems, Inc. 7736 Zionsville Rd., Indianapolis IN
510(k) summary
Statement
Third party review
No

Clearances, product code JMK

Trailing 12 months

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

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