Home / 510(k) Clearances / K844188

510(k) K844188

CORNING CALCIUM PH ANALYZER 634 by Corning Medical & Scientific — Product Code JFP

K844188 is an FDA 510(k) premarket notification submitted by Corning Medical & Scientific for the device "CORNING CALCIUM PH ANALYZER 634". The FDA issued a decision of Substantially Equivalent on February 4, 1985. The device falls under product code JFP (Electrode, Ion Specific, Calcium), a Class II device regulated under 21 CFR 862.1145. Corning Medical & Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1985
Date Received
October 26, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

Other clearances by Corning Medical & Scientific

  • K875122 — DISPOSABLE STERILE SYRINGE FILTERS (January 12, 1988)
  • K872273 — CORNING EASY WASH ELISA PLATES (July 7, 1987)
  • K872076 — CORNING DISPOSABLE ROLLER BOTTLES (June 15, 1987)
  • K863789 — CORNING ELISA PLATES (October 3, 1986)
  • K854024 — CORNING MAGIC MAB HCG RADIOIMMUNOASSAY (November 26, 1985)
  • K853634 — CORNING CELL WELLS-MULTIPLE WELL PLATES (September 16, 1985)
  • K851939 — CORNING CERTAIN -ISE (June 14, 1985)
  • K851329 — MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA (June 13, 1985)
  • K850806 — CORNING BLOOD COLLECTION CAPILLARY TUBES (March 25, 1985)
  • K850617 — CORNING 780 FLUOROMETER/DENSITOMETER (March 12, 1985)

Other clearances for product code JFP

  • K230300 — i-STAT CG8+ cartridge with the i-STAT 1 System (October 27, 2023)
  • K191360 — i-STAT CHEM8+ cartridge with the i-STAT 1 System (February 14, 2020)
  • K191626 — Stat Profile Prime ES Comp Plus Analyzer System (August 16, 2019)
  • K152327 — EasyLyte Na/K/Cl/Ca Analyzer (December 1, 2016)
  • K984299 — AVL OPTI CRITICAL CARE ANALYZER (December 11, 1998)
  • K972673 — AVL 9181 ELECTROLYTE ANALYZER (August 20, 1997)
  • K963694 — EASYLYTE CALCIUM/CHLORIDE ANALYZER (November 27, 1996)
  • K961458 — AVL 9180 ELECTROLYTE ANALYZER (June 12, 1996)
  • K960120 — STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS (March 11, 1996)
  • K943091 — EASY LYTE CALCIUM ANALYZER (January 17, 1995)

FDA data resources