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510(k) K873625

CHEMELIA ENZYME IMMUNOASSAY FOR (TSH) by Boots-Celltech Diagnostics, Inc. — Product Code JLM

K873625 is an FDA 510(k) premarket notification submitted by Boots-Celltech Diagnostics, Inc. for the device "CHEMELIA ENZYME IMMUNOASSAY FOR (TSH)". The FDA issued a decision of Substantially Equivalent on October 20, 1987. The device falls under product code JLM (Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase), a Class II device regulated under 21 CFR 864.7360. Boots-Celltech Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1987
Date Received
September 8, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase
Device Class
Class II
Regulation Number
864.7360
Review Panel
HE
Submission Type

Other clearances by Boots-Celltech Diagnostics, Inc.

  • K871877 — IDEIA HERPES SIMPLEX VIRUS TEST (November 17, 1989)
  • K880799 — MODIFIED IDEIA CHLAMYDIA TEST (December 8, 1988)
  • K880758 — SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY (April 18, 1988)
  • K874875 — CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) (March 24, 1988)
  • K872958 — IMAGEN INFLUENZA VIRUS A AND B TESTMI (February 24, 1988)
  • K872843 — OVEIA (TM) DUAL ANALYTE (February 2, 1988)
  • K872056 — MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST (June 15, 1987)
  • K870602 — IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST (May 8, 1987)
  • K864998 — IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT (April 20, 1987)
  • K864539 — MODIFIED IMAGEN(TM) CHLAMYDIA TEST (March 12, 1987)

FDA data resources