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510(k) K802035

BAKER DIAG. ULTRARATE CO2 REAGENT KIT by J.T. Baker Chemical Co. — Product Code JFL

K802035 is an FDA 510(k) premarket notification submitted by J.T. Baker Chemical Co. for the device "BAKER DIAG. ULTRARATE CO2 REAGENT KIT". The FDA issued a decision of Substantially Equivalent on September 26, 1980. The device falls under product code JFL (Ph Rate Measurement, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. 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 22, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ph Rate Measurement, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
Review Panel
CH
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)
  • K801795 — BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT. (September 16, 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)
  • 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 JFL

  • K191298 — i-STAT CHEM8+ cartridge with the i-STAT 1 System (February 7, 2020)
  • K040975 — GENCHEM CO2 ACID REAGENT (December 27, 2004)
  • K014034 — MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) (December 18, 2001)
  • K963541 — SIGMA DIAGNOSTICS CO2 ACID REAGENT (October 24, 1996)
  • K963538 — SIGMA DIAGNOSTICS CO2ALKALINE BUFFER (October 11, 1996)
  • K963540 — SIGMA DIAGNOSTICS ELECTROLYTE BUFFER (September 27, 1996)
  • K963005 — NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) (August 23, 1996)
  • K933696 — SIGMA ELECTROLYTE REFERENCE REAGENT (January 3, 1994)
  • K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT (December 17, 1993)
  • K933692 — SIGMA CO2 ACID REAGENT (December 9, 1993)

FDA data resources