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510(k) K881773

DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET by Casco Standards — Product Code JJR

K881773 is an FDA 510(k) premarket notification submitted by Casco Standards for the device "DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET". The FDA issued a decision of Substantially Equivalent on June 10, 1988. The device falls under product code JJR (Electrolyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Casco Standards has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1988
Date Received
April 26, 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 Casco Standards

  • K981436 — DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109 (April 24, 1998)
  • K972904 — DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL (February 20, 1998)
  • K962629 — DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR (September 13, 1996)
  • K961750 — DOCUMENT CARDIAC ASSAYED CONTROL (July 22, 1996)
  • K962630 — DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL (July 22, 1996)
  • K960244 — DOCUMENT TDM ULTRA ASSAYED CONTROL (March 22, 1996)
  • K955155 — DOCUMENT TDM ULTRA UNASSAYED CONTROL (December 20, 1995)
  • K950469 — DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET (April 11, 1995)
  • K945718 — DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET (January 17, 1995)
  • K945315 — DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL (December 9, 1994)

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