510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970396Substantially Equivalent

Human Chorionic Gonadotropin Calibrator

Dade Chemistry Systems, Inc., Glasgow DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970396 is the FDA 510(k) clearance record for HUMAN CHORIONIC GONADOTROPIN CALIBRATOR, a class II device, cleared for Dade Chemistry Systems, Inc. on under FDA product code JIW (Calibrator, Surrogate). FDA records list 13 510(k) clearances for Dade Chemistry Systems, Inc., from to . As of , FDA records show no recalls naming K970396.

Clearance record

Decision date
Received
(17 days to decision)
Product code
JIW Calibrator, Surrogate
Regulation
21 CFR 862.1150
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Dade Chemistry Systems, Inc. Rt. 896, Glascow Bldg. 500, Glasgow DE
510(k) summary
Summary
Third party review
No

Clearances, product code JIW

Trailing 12 months

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

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