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510(k) K780652

HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 by The London Co. — Product Code JKS

K780652 is an FDA 510(k) premarket notification submitted by The London Co. for the device "HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2". The FDA issued a decision of Substantially Equivalent on July 27, 1978. The device falls under product code JKS (Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide), a Class I device regulated under 21 CFR 862.3220. The London Co. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1978
Date Received
April 17, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
Device Class
Class I
Regulation Number
862.3220
Review Panel
TX
Submission Type

Other clearances by The London Co.

  • K802846 — TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY. (December 17, 1980)
  • K801848 — ICA1 IONIZED CALCIUM ANALYZER (October 31, 1980)
  • K800224 — RADIOMETER ACID BASE LABORATORY-ABL-3 (February 22, 1980)
  • 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 JKS

  • K951485 — AVOXIMETER 4000 (November 6, 1995)
  • K863825 — CO-OXIMETER SOLUTIONS (November 24, 1986)
  • K862253 — IL 482 CO-OXIMETER (July 29, 1986)
  • K853990 — OSM3 HEMOXIMETER (December 30, 1985)
  • K833693 — TEE ADAPTER 9890-FLUSH WINDING 282 (December 30, 1983)
  • K833211 — BILE SALTS MIXTURE (October 27, 1983)
  • K832066 — CONTROL 282 (September 29, 1983)

FDA data resources