510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K894207Substantially Equivalent

Ck-Mb/ld-1 Control System

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

K894207 is the FDA 510(k) clearance record for CK-MB/LD-1 CONTROL SYSTEM, a class I device, cleared for Boehringer Mannheim Corp. on under FDA product code JJT (Enzyme Controls (Assayed And Unassayed)). FDA records list 340 510(k) clearances for Boehringer Mannheim Corp., from to . As of , FDA records show no recalls naming K894207.

Clearance record

Decision date
Received
(70 days to decision)
Product code
JJT Enzyme Controls (Assayed And Unassayed)
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Boehringer Mannheim Corp. 9115 Hague Rd., Indianapolis IN
Third party review
No

Clearances, product code JJT

Trailing 12 months

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

FDA records show no clearances under product code JJT in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JJT, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260