Home / 510(k) Clearances / K801662

510(k) K801662

J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH. by J.T. Baker Chemical Co. — Product Code DEP

K801662 is an FDA 510(k) premarket notification submitted by J.T. Baker Chemical Co. for the device "J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH.". The FDA issued a decision of Substantially Equivalent on September 16, 1980. The device falls under product code DEP (Lambda, Peroxidase, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. J.T. Baker Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1980
Date Received
July 21, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lambda, Peroxidase, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
PA
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)
  • K801661 — J.T. BAKER CERULOPLASMIN NEPHELOMETRIC (September 16, 1980)
  • K801669 — J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO (September 16, 1980)
  • K801795 — BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT. (September 16, 1980)
  • K801362 — ALBUMIN NEPHELOMETRIC ASSAY (July 21, 1980)
  • K801432 — HEMOPEXIN NEPHELOMETRIC ASSAY (July 8, 1980)
  • K801433 — HAPTOGLOBIN NEPHELOMETRIC ASSAY (July 8, 1980)

FDA data resources