510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K873625Substantially Equivalent

Chemelia Enzyme Immunoassay for (Tsh)

Boots-Celltech Diagnostics, Inc., Berkshire, England, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K873625 is the FDA 510(k) clearance record for CHEMELIA ENZYME IMMUNOASSAY FOR (TSH), a class II device, cleared for Boots-Celltech Diagnostics, Inc. on under FDA product code JLM (Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase). FDA records list 20 510(k) clearances for Boots-Celltech Diagnostics, Inc., from to . As of , FDA records show no recalls naming K873625.

Clearance record

Decision date
Received
(42 days to decision)
Product code
JLM Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase
Regulation
21 CFR 864.7360
Device class
Class II
Review panel
Hematology
Applicant
Boots-Celltech Diagnostics, Inc. 240 Bath Rd., Berkshire, England, GB
Third party review
No

Clearances, product code JLM

Trailing 12 months

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

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