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ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM

FDA 510(k) clearance K780913 · decided 1978-06-22

Clearance details

K-number
K780913
Device name
ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM
Applicant
Beckman Instruments, Inc.
Decision
Substantially Equivalent
Date received
1978-06-05
Decision date
1978-06-22
Days to decision
17 days
Clearance type
Traditional
Product code
DCF
Device class
2
Regulation number
866.5040
Medical specialty
Immunology
Advisory committee
Immunology
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
Optilite Low Level Albumin Kit (K153560)The Binding Site Group , Ltd.2016-08-25
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Urine/CSF Albumin, Urine/CSF Albumin Calibrator (K142346)Beckman Coulter Ireland, Inc.2014-10-15
HUMAN ALBUMIN CSF KIT (K121045)The Binding Site Group , Ltd.2013-06-19
TINA-QUANT ALBUMIN GEN.2 (K113072)Roche Diagnostics Operations2012-05-14
EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR (K101089)Medica Corp.2011-07-13
TINA-QUANT ALBUMIN GEN 2 (K101203)Roche Diagnostics2010-09-10
COBAS 8000 MODULAR SERIES ANALYZER (K100853)Roche Diagnostics Corp.2010-09-09
K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR (K091486)Kamiya Biomedical Co.2010-04-29
SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 (K082251)Beckman Coulter, Inc.2009-04-08
DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL (K061990)Dade Behring, Inc.2006-09-19
NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL (K053553)Polymedco, Inc.2006-03-09

Recalls involving this device

No recalls on record reference this clearance.