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
K981373Substantially Equivalent

Alkphase-B Assay Kit

Metra Biosystems, Inc., Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981373 is the FDA 510(k) clearance record for ALKPHASE-B ASSAY KIT, a class II device, cleared for Metra Biosystems, Inc. on under FDA product code CIN (Electrophoretic Separation, Alkaline Phosphatase Isoenzymes). FDA records list 7 510(k) clearances for Metra Biosystems, Inc., from to . As of , FDA records show one recall naming K981373.

Clearance record

Decision date
Received
(41 days to decision)
Product code
CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Regulation
21 CFR 862.1050
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Metra Biosystems, Inc. 265 N. Whisman Rd., Mountain View CA
510(k) summary
Statement
Third party review
No

Clearances, product code CIN

Trailing 12 months

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

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