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510(k) K801909

LSA 290 ASSAY REAGENTS/NEPHELOMETRIC by J.T. Baker Chemical Co. — Product Code DEX

K801909 is an FDA 510(k) premarket notification submitted by J.T. Baker Chemical Co. for the device "LSA 290 ASSAY REAGENTS/NEPHELOMETRIC". The FDA issued a decision of Substantially Equivalent on September 26, 1980. The device falls under product code DEX (Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5420. J.T. Baker Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1980
Date Received
August 11, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5420
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)
  • K802035 — BAKER DIAG. ULTRARATE CO2 REAGENT KIT (September 26, 1980)
  • K801669 — J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO (September 16, 1980)
  • K801661 — J.T. BAKER CERULOPLASMIN NEPHELOMETRIC (September 16, 1980)
  • K801662 — J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH. (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)
  • K801434 — J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS (July 8, 1980)

Other clearances for product code DEX

  • K823765 — ANTI SERA TO HUMAN OROSCOMUCOID (December 30, 1982)
  • K791341 — HUMAN ALPHA, ACID GLYCOPROTEIN (August 16, 1979)
  • K781023 — ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU (August 14, 1978)
  • K760143 — SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN (July 20, 1976)

FDA data resources