JJX · Class I · 21 CFR 862.1660

FDA Product Code JJX: Single (specified) Analyte Controls (assayed And Unassayed)

Leading manufacturers include Roche Diagnostics, Siemens Healthcare Diagnostics, Inc. and Boehringer Mannheim Corp..

493
Total
493
Cleared
62d
Avg days
1976
Since
493 devices
337–360 of 493
Cleared Sep 21, 1993
AIA-PACK PA CALIBRATION VERIFICATION/LINEARITY TES
K932178
Tosoh Medics, Inc.
Chemistry · 139d
Cleared Aug 16, 1993
IMMULITE TSH THIRD GENERATION CONTROL
K930007
Diagnostic Products Corp.
Chemistry · 224d
Cleared Aug 02, 1993
DOCUMENT CHEM IV CALIBRATION VERIFICATION TEST SET
K932870
Casco Standards
Chemistry · 49d
Cleared Jul 28, 1993
CKMB ISOENZYME CONTROL(HUMAN) LEVEL 1,2,& 3
K932658
More Diagnostics
Chemistry · 56d
Cleared Jul 28, 1993
MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM
K932659
More Diagnostics
Chemistry · 56d
Cleared Jun 29, 1993
CANNABINOID URINE CONTROLS
K932113
Diagnostic Reagents, Inc.
Toxicology · 57d
Cleared Jun 22, 1993
QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI)
K931761
Quidel Corp.
Chemistry · 75d
Cleared May 14, 1993
AIA-PACK IGE CALIBRATION VERIFICATION TEST SET
K924859
Tosoh Medics, Inc.
Immunology · 228d
Cleared Mar 22, 1993
AUTOSTAT ANTI-DSDNA
K925783
Cogent Diagnotics , Ltd.
Immunology · 140d
Cleared Mar 04, 1993
AIA-PACK AFP CALIBRATION VERIFICATION TEST SET
K924860
Tosoh Medics, Inc.
Chemistry · 157d
Cleared Feb 18, 1993
NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL
K925906
Analytical Control Systems, Inc.
Chemistry · 90d
Cleared Feb 17, 1993
TANDEM-E IGE II CALIBRATION VERIFICATION SET
K922754
Hybritech, Inc.
Immunology · 254d
Cleared Feb 05, 1993
KODAK AMERLITE CK-MB CONTROL SERA LAN.4413
K925880
Eastman Kodak Company
Chemistry · 78d
Cleared Jan 28, 1993
SUGAR CHEX LINEARITY FOR THE ONE TOUCH
K925479
Streck Laboratories, Inc.
Chemistry · 147d
Cleared Jan 26, 1993
REFRACTROL-SP
K926095
Medical Specialties, Inc.
Chemistry · 55d
Cleared Jan 11, 1993
DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD
K924493
Casco Standards
Chemistry · 136d
Cleared Jan 11, 1993
ASIA-PACK TSH CALIBRATION VERIFICATION TEST SET
K924852
Tosoh Medics, Inc.
Chemistry · 105d
Cleared Jan 11, 1993
AIA-PACK PRL CALIBRATION VERIFICATION TEST SET
K924856
Tosoh Medics, Inc.
Chemistry · 105d
Cleared Dec 28, 1992
AIA-PACK BHCG CALIBRATION VERIFICATION TEST SET
K924853
Tosoh Medics, Inc.
Chemistry · 91d
Cleared Dec 28, 1992
AIA-PACK HCG CALIBRATION VERIFICATION TEST SET
K924862
Tosoh Medics, Inc.
Chemistry · 91d
Cleared Nov 16, 1992
AIA-PACK PAP CALIBRATION VERIFICATION TEST SET
K924854
Tosoh Medics, Inc.
Chemistry · 49d
Cleared Nov 16, 1992
AIA-PACK T-U CALIBRATION VERIFICATION TEST SET
K924855
Tosoh Medics, Inc.
Chemistry · 49d
Cleared Nov 16, 1992
AIA-PACK FSH CALIBRATION VERIFICATION TEST SET
K924863
Tosoh Medics, Inc.
Chemistry · 49d
Cleared Nov 05, 1992
DOCUMENT CHEM III CALIBRATION VERIFICATION TEST
K923793
Casco Standards
Chemistry · 100d