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510(k) K881655

SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL by Biomedical Research & Development Laboratories, Inc. — Product Code JJR

K881655 is an FDA 510(k) premarket notification submitted by Biomedical Research & Development Laboratories, Inc. for the device "SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL". The FDA issued a decision of Substantially Equivalent on May 27, 1988. The device falls under product code JJR (Electrolyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Biomedical Research & Development Laboratories, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1988
Date Received
April 15, 1988
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 Biomedical Research & Development Laboratories, Inc.

  • K884693 — UNIVERSAL(TM) ION SELECT ELECTRODE STANDARDS (December 15, 1988)
  • K834474 — H.P.T. HOME PREG. TEST KIT & A.P.T. (September 28, 1984)

Other clearances for product code JJR

  • K990971 — EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816 (April 27, 1999)
  • K960592 — ELECTROLYTE STANDARDS (May 13, 1996)
  • K955630 — RNA MEDICAL HEMAT CONTROL (March 1, 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)

FDA data resources