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510(k) K813447

SOLUTIONS & BUFFERS FOR BLOOD GAS INSTR by Rna Medical Corp. — Product Code JIS

K813447 is an FDA 510(k) premarket notification submitted by Rna Medical Corp. for the device "SOLUTIONS & BUFFERS FOR BLOOD GAS INSTR". The FDA issued a decision of Substantially Equivalent on December 31, 1981. The device falls under product code JIS (Calibrator, Primary), a Class II device regulated under 21 CFR 862.1150. Rna Medical Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1981
Date Received
December 1, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Primary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by Rna Medical Corp.

  • K851362 — STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF (June 12, 1985)
  • K844589 — OSMOLARITY STANDARDS (March 1, 1985)
  • K842131 — FORMACLEAR- & MULTIPLE (September 10, 1984)
  • K842519 — BLOOD GAS FLUSH SOL. & FLUSH AGENT 1302 (August 17, 1984)
  • K830843 — BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU- (April 28, 1983)

Other clearances for product code JIS

  • K122126 — DIRECT LDL/HDL CHOLESTEROL CALIBRATOR (August 14, 2012)
  • K061251 — DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR (May 31, 2006)
  • K060266 — DIMENSION IRON CALIBRATOR (March 9, 2006)
  • K053104 — DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR (December 23, 2005)
  • K032697 — DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) (November 7, 2003)
  • K032608 — GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER (October 21, 2003)
  • K032296 — VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS (August 13, 2003)
  • K030964 — CALIBRATION PLASMA LMW HEPARIN (June 6, 2003)
  • K030546 — CRP (II) CALIBRATORS (June 2, 2003)
  • K030320 — WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CON (April 11, 2003)

FDA data resources