510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K900788Substantially Equivalent

Modified Apsara Clinical Diagnostic Analyzer

Datachem, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900788 is the FDA 510(k) clearance record for MODIFIED APSARA CLINICAL DIAGNOSTIC ANALYZER, a class II device, cleared for Datachem, Inc. on under FDA product code CEM (Electrode, Ion Specific, Potassium). FDA records list 5 510(k) clearances for Datachem, Inc., from to . As of , FDA records show no recalls naming K900788.

Clearance record

Decision date
Received
(135 days to decision)
Product code
CEM Electrode, Ion Specific, Potassium
Regulation
21 CFR 862.1600
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Datachem, Inc. 7742 Moller Rd., Indianapolis IN
Third party review
No

Clearances, product code CEM

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