Home / 510(k) Clearances / K801848

510(k) K801848

ICA1 IONIZED CALCIUM ANALYZER by The London Co. — Product Code JFP

K801848 is an FDA 510(k) premarket notification submitted by The London Co. for the device "ICA1 IONIZED CALCIUM ANALYZER". The FDA issued a decision of Substantially Equivalent on October 31, 1980. The device falls under product code JFP (Electrode, Ion Specific, Calcium), a Class II device regulated under 21 CFR 862.1145. The London Co. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1980
Date Received
August 4, 1980
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 The London Co.

  • K802846 — TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY. (December 17, 1980)
  • K800224 — RADIOMETER ACID BASE LABORATORY-ABL-3 (February 22, 1980)
  • K780652 — HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 (July 27, 1978)
  • K771444 — QUALICHECK TM (August 16, 1977)
  • K771263 — RADIOMHTER OSM-2 HEMOXIMETER (August 3, 1977)
  • K760229 — ACID BASE SYSTEM, RADIOMETER AUTOMATED (August 26, 1976)

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