510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864082Substantially Equivalent

Reflotron(r) Alt (Gpt)

Boehringer Mannheim Corp., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864082 is the FDA 510(k) clearance record for REFLOTRON(R) ALT (GPT), a class I device, cleared for Boehringer Mannheim Corp. on under FDA product code CKD (Hydrazone Colorimetry, Alt/Sgpt). FDA records list 340 510(k) clearances for Boehringer Mannheim Corp., from to . As of , FDA records show one recall naming K864082.

Clearance record

Decision date
Received
(45 days to decision)
Product code
CKD Hydrazone Colorimetry, Alt/Sgpt
Regulation
21 CFR 862.1030
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Boehringer Mannheim Corp. 9115 Hague Rd., Indianapolis IN
Third party review
No

Clearances, product code CKD

Trailing 12 months

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

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