Atlas FDA

FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY

FDA 510(k) clearance K791596 · decided 1979-10-17

Clearance details

K-number
K791596
Device name
FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY
Applicant
Bio-Rad
Decision
Substantially Equivalent
Date received
1979-08-15
Decision date
1979-10-17
Days to decision
63 days
Clearance type
Traditional
Product code
KLB
Device class
2
Regulation number
862.3900
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
ONLINE TDM TOBRAMYCIN (K060853)Roche Diagnostics Corp.2006-06-09
IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS) (K012312)Diagnostic Products Corp.2001-08-20
EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS (K003341)Syva Co., Dade Behring, Inc.2001-01-22
DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD (K904304)E.I. Dupont DE Nemours & Co., Inc.1990-10-26
IL TOBRAMYCIN ASSAY (K903192)Instrumentation Laboratory CO1990-08-22
TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD (K893913)Technicon Instruments Corp.1989-08-21
EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAY (K882294)Syva Co.1988-07-01
EMIT TOBRAMYCIN ASSAY (K874223)Syva Co.1987-11-13
IN-VITRO TEST DETERMINATION OF TOBRAMYCIN (K854184)Clinical Data, Inc.1985-12-04
ACA TOBRAMY-CIN ANALYTICAL TEST PACK (K852671)E.I. Dupont DE Nemours & Co., Inc.1985-07-22
TOBRAMYCIN REAGENT (K832763)Biosan Laboratories, Inc.1984-03-23
TOBRAMYCIN ANALYTICAL TEST PACK-ACA (K832985)E.I. Dupont DE Nemours & Co., Inc.1983-10-27

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S002)Bio-Rad1996-03-01
BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S001)Bio-Rad1991-03-14
BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032)Bio-Rad1989-07-24