510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K941497Substantially Equivalent

Solarcare Alanine Aminotransferase Micro-Plate Assay

Solarcare, Inc., Bethlehem PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941497 is the FDA 510(k) clearance record for SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY, a class I device, cleared for Solarcare, Inc. on under FDA product code CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt). FDA records list 6 510(k) clearances for Solarcare, Inc., from to . As of , FDA records show no recalls naming K941497.

Clearance record

Decision date
Received
(57 days to decision)
Product code
CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt
Regulation
21 CFR 862.1030
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Solarcare, Inc. 1745 Eaton Ave., Bethlehem PA
510(k) summary
Statement
Third party review
No

Clearances, product code CKA

Trailing 12 months

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

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