Home / 510(k) Clearances / K801432

510(k) K801432

HEMOPEXIN NEPHELOMETRIC ASSAY by J.T. Baker Chemical Co. — Product Code CZX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1980
Date Received
June 18, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemopexin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5490
Review Panel
IM
Submission Type

Other clearances by J.T. Baker Chemical Co.

  • K803128 — SERIES 810 PLATELET ANALYZER (April 3, 1981)
  • K802080 — BAKER DIAG. ULTRARATE CHLORIDE KIT (October 10, 1980)
  • K801909 — LSA 290 ASSAY REAGENTS/NEPHELOMETRIC (September 26, 1980)
  • K802035 — BAKER DIAG. ULTRARATE CO2 REAGENT KIT (September 26, 1980)
  • K801662 — J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH. (September 16, 1980)
  • K801669 — J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO (September 16, 1980)
  • K801661 — J.T. BAKER CERULOPLASMIN NEPHELOMETRIC (September 16, 1980)
  • K801795 — BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT. (September 16, 1980)
  • K801362 — ALBUMIN NEPHELOMETRIC ASSAY (July 21, 1980)
  • K801433 — HAPTOGLOBIN NEPHELOMETRIC ASSAY (July 8, 1980)

Other clearances for product code CZX

  • K790713 — ANTISERUM TO HUMAN HEMOPEXIN (September 4, 1979)
  • K780250 — HEMOPEXIN NEPHELOMETRIC ASSAYS (February 28, 1978)