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510(k) K863825

CO-OXIMETER SOLUTIONS by D.R.G. Scientific Industries — Product Code JKS

K863825 is an FDA 510(k) premarket notification submitted by D.R.G. Scientific Industries for the device "CO-OXIMETER SOLUTIONS". The FDA issued a decision of Substantially Equivalent on November 24, 1986. The device falls under product code JKS (Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide), a Class I device regulated under 21 CFR 862.3220. D.R.G. Scientific Industries has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1986
Date Received
September 30, 1986
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 D.R.G. Scientific Industries

  • K892329 — OSMOMETER STANDARD SOLUTIONS (October 31, 1989)
  • K870889 — ACID FUCHSIN SOLUTIONS (July 8, 1987)
  • K863880 — BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD. (November 24, 1986)
  • K863824 — SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT. (October 24, 1986)

Other clearances for product code JKS

  • K951485 — AVOXIMETER 4000 (November 6, 1995)
  • 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)
  • K780652 — HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 (July 27, 1978)

FDA data resources