510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K924257Substantially Equivalent

Testosterone Serozyme(tm) Enzyme Immunoassay

Serono-Baker Diagnostics, Inc., Allentown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924257 is the FDA 510(k) clearance record for TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY, a class I device, cleared for Serono-Baker Diagnostics, Inc. on under FDA product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone). FDA records list 23 510(k) clearances for Serono-Baker Diagnostics, Inc., from to . As of , FDA records show no recalls naming K924257.

Clearance record

Decision date
Received
(98 days to decision)
Product code
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Regulation
21 CFR 862.1680
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Serono-Baker Diagnostics, Inc. 100 Cascade Dr., Allentown PA
510(k) summary
Statement
Third party review
No

Clearances, product code CDZ

Trailing 12 months
1 clearance under product code CDZ in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CDZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260