510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K930810Substantially Equivalent

Tandem-R Ostase Immunoradiometric Assay

Hybritech, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930810 is the FDA 510(k) clearance record for TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY, a class II device, cleared for Hybritech, Inc. on under FDA product code CIN (Electrophoretic Separation, Alkaline Phosphatase Isoenzymes). FDA records list 63 510(k) clearances for Hybritech, Inc., from to . As of , FDA records show no recalls naming K930810.

Clearance record

Decision date
Received
(328 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
Hybritech, Inc. P.O. Box 269006, San Diego CA
510(k) summary
Summary
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