JJR · Class I · 21 CFR 862.1660

FDA Product Code JJR: Electrolyte Controls (assayed And Unassayed)

Leading manufacturers include Quantimetrix Corp., Bionostics, Inc. and Avl Scientific Corp..

17
Total
17
Cleared
55d
Avg days
1979
Since

FDA 510(k) Cleared Electrolyte Controls (assayed And Unassayed) Devices (Product Code JJR)

17 devices
1–17 of 17
Cleared Apr 27, 1999
EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816
K990971
Medica Corp.
Chemistry · 35d
Cleared Mar 01, 1996
RNA MEDICAL HEMAT CONTROL
K955630
Bionostics, Inc.
Hematology · 81d
Cleared May 02, 1995
AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL
K951435
Aalto Scientific, Ltd.
Chemistry · 36d
Cleared Oct 04, 1994
SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING
K943925
Quantimetrix Corp.
Chemistry · 53d
Cleared Oct 30, 1989
CIBA CORNING CERTAIN LYTE
K894576
Ciba Corning Diagnostics Corp.
Chemistry · 101d
Cleared Oct 04, 1989
QCLYTE PROTEIN-BASED ISE CONTROL
K895582
Baxter Healthcare Corp
Chemistry · 19d
Cleared Jun 10, 1988
DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET
K881773
Casco Standards
Chemistry · 45d
Cleared Mar 24, 1988
PROTEIN BASE ISE CONTROL
K880710
Bionostics, Inc.
Chemistry · 31d
Cleared Sep 29, 1986
AVL ISE-TROL ELECTROLYTE CONTROL
K863333
Avl Scientific Corp.
Chemistry · 32d
Cleared Apr 13, 1984
HUMAN SERUM ELECTROLYTE CONTROL-LIQUID
K834505
Quantimetrix Corp.
Chemistry · 114d

About Product Code JJR - Regulatory Context