JJY · Class I · 21 CFR 862.1660

FDA Product Code JJY: Multi-analyte Controls, All Kinds (assayed)

Leading manufacturers include Bio-Rad, Medical Analysis Systems, Inc. and Cliniqa Corporation.

673
Total
673
Cleared
64d
Avg days
1976
Since
673 devices
265–288 of 673
Cleared Oct 18, 1993
TRI-POINT BRAND LIQUIMMUNE IMMUNOASSAY CONTR 1,2 & 3
K934056
Medical Analysis Systems, Inc.
Chemistry · 60d
Cleared Sep 24, 1993
DADE URINE CHEMISTRY CONTROL, LEVEL 1 & LEVEL 2
K933435
Baxter Diagnostics, Inc.
Chemistry · 72d
Cleared Sep 01, 1993
BECKMAN VIGIL PLUS CONTROL
K930850
Beckman Instruments, Inc.
Immunology · 195d
Cleared Aug 11, 1993
LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2
K933317
Bio-Rad
Chemistry · 35d
Cleared Aug 05, 1993
DADE(R) TUMOR MARKER CONTROL
K924919
Baxter Diagnostics, Inc.
Immunology · 310d
Cleared Jul 28, 1993
TRI-POINT LIQUIMMUNE IMMUONASSAY CONTROL, L-1,2,3
K931366
Medical Analysis Systems, Inc.
Immunology · 133d
Cleared Jun 29, 1993
LIQUICHEK SPINAL FLUID CONTROL LEVELS I AND II
K932076
Bio-Rad
Chemistry · 61d
Cleared Jun 29, 1993
DOCUMENT ENZYME
K932458
Casco Standards
Chemistry · 39d
Cleared Jun 28, 1993
MULTITROL IMMUNOLOGY CONTROL
K923663
Behring Diagnostics, Inc.
Immunology · 341d
Cleared Jun 15, 1993
ANALYZER: STAT PROFILE PLUS 10 ANALYZER
K931373
Nova Biomedical Corp.
Chemistry · 89d
Cleared May 12, 1993
DOCULMENT(R) CHEM VI CALIBRATION VERIF TEST SET
K931139
Casco Standards
Chemistry · 68d
Cleared Mar 09, 1993
CALIBRATION VERIFICATION KIT OR CVK
K924802
Radiometer America, Inc.
Chemistry · 166d
Cleared Mar 01, 1993
QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL
K925256
Quantimetrix Corp.
Hematology · 133d
Cleared Jan 05, 1993
DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III
K926046
Baxter Diagnostics, Inc.
Chemistry · 35d
Cleared Dec 18, 1992
SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479
K924915
Helena Laboratories
Hematology · 80d
Cleared Nov 05, 1992
DOCUMENT CHEM I CALIBRATION VERIFICATION TEST SET
K923795
Casco Standards
Chemistry · 100d
Cleared Oct 13, 1992
MULTIQUAL UNASSAYED PRODUCTS
K923632
Ciba Corning Diagnostics Corp.
Chemistry · 84d
Cleared Oct 13, 1992
MULTIQUAL ASSAY PRODUCTS
K923633
Ciba Corning Diagnostics Corp.
Chemistry · 84d
Cleared Sep 25, 1992
KODAK AMERLITE TOTAL THYROID CONTROL SERA
K923740
Eastman Kodak Company
Chemistry · 60d
Cleared Sep 02, 1992
MONI-TROL-L AND MONI-TROL-XL
K920291
Medical Analysis Systems, Inc.
Chemistry · 224d
Cleared Aug 10, 1992
AMERLITE FREE THYROID CONTROL SERA LAN.4002
K923165
Eastman Kodak Company
Chemistry · 42d
Cleared Jul 10, 1992
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3
K922046
Bio-Rad
Chemistry · 70d
Cleared Jul 07, 1992
DADE URINE CHEMISTRY CONTROL LEVELS I AND II
K920636
Baxter Diagnostics, Inc.
Chemistry · 146d
Cleared Jun 19, 1992
KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024
K920927
Helena Laboratories
Chemistry · 112d