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510(k) K955630

RNA MEDICAL HEMAT CONTROL by Bionostics, Inc. — Product Code JJR

K955630 is an FDA 510(k) premarket notification submitted by Bionostics, Inc. for the device "RNA MEDICAL HEMAT CONTROL". The FDA issued a decision of Substantially Equivalent on March 1, 1996. The device falls under product code JJR (Electrolyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Bionostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1996
Date Received
December 11, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrolyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Bionostics, Inc.

  • K131136 — GLUCOSE METER-CHECK SOLUTION FOR TAIDOC (May 31, 2013)
  • K123851 — GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK (February 14, 2013)
  • K123966 — GLUCOSE METER-CHECK SOLUTION FOR BAYER (January 25, 2013)
  • K113764 — GLUCOSE METER-CHECK SOLUTION FOR INFOPIA (January 30, 2012)
  • K112352 — GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT (December 23, 2011)
  • K112356 — GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE (September 19, 2011)
  • K103553 — LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION (February 10, 2011)
  • K101831 — ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800 (October 1, 2010)
  • K091914 — OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION (November 6, 2009)
  • K081478 — RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS (October 6, 2008)

Other clearances for product code JJR

  • K990971 — EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816 (April 27, 1999)
  • K960592 — ELECTROLYTE STANDARDS (May 13, 1996)
  • K951435 — AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL (May 2, 1995)
  • K943925 — SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING (October 4, 1994)
  • K934641 — I-STAT CONTROL LEVELS 1,2,3 (December 9, 1993)
  • K912513 — ELECTROLYTE CONTROL (July 19, 1991)
  • K902266 — ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED) (June 6, 1990)
  • K894576 — CIBA CORNING CERTAIN LYTE (October 30, 1989)
  • K895582 — QCLYTE PROTEIN-BASED ISE CONTROL (October 4, 1989)
  • K881773 — DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET (June 10, 1988)

FDA data resources