510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K974306Substantially Equivalent

Sangui Biotech, Inc. Intact-Pth (Parathyroid Hormone) Elisa

Sangui Biotech, Inc., Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974306 is the FDA 510(k) clearance record for SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA, a class II device, cleared for Sangui Biotech, Inc. on under FDA product code CEW (Radioimmunoassay, Parathyroid Hormone). FDA records list 5 510(k) clearances for Sangui Biotech, Inc., from to . As of , FDA records show one recall naming K974306.

Clearance record

Decision date
Received
(36 days to decision)
Product code
CEW Radioimmunoassay, Parathyroid Hormone
Regulation
21 CFR 862.1545
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Sangui Biotech, Inc. 1508 Brookhollow Dr., #354, Santa Ana CA
510(k) summary
Summary
Third party review
No

Clearances, product code CEW

Trailing 12 months

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

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