Atlas FDA

CPK-L TUBE

FDA 510(k) clearance K781149 · decided 1978-08-14

Clearance details

K-number
K781149
Device name
CPK-L TUBE
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Decision
Substantially Equivalent
Date received
1978-07-11
Decision date
1978-08-14
Days to decision
34 days
Clearance type
Traditional
Product code
CGS
Device class
2
Regulation number
862.1215
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Washington, DC, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Bd Becton Dickinson Vacutainer Systems Preanalytic

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
Pointe Scientific Creatinine Kinase (CK) Reagent Set (K191296)Medtest DX2020-08-11
SEKURE Creatine Kinase Assay (K182702)Sekisui Diagnostics P.E.I., Inc.2019-04-17
ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator (K160724)Siemens Healthcare Diagnostics, Inc.2016-09-07
RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR (K123977)Randox Laboratories, Ltd.2013-11-21
CPK REAGENT (K112416)Vital Diagnostics (Manufacturing) Ptyltd2011-11-09
DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE (K083465)Siemens Healthcare Diagnostics2009-02-27
DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32 (K081731)Siemens Healthcare Diagnostics2008-08-29
CREATINE KINASE LIQUID REAGENT, MODEL C519-440 (K072548)Teco Diagnostics2008-04-18
CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (K062737)Horiba Abx2007-06-12
SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS (K051648)Arkray, Inc.2006-01-31
OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 (K043202)Olympus America, Inc.2004-12-23
WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA (K021332)Wiener Laboratories Saic2002-07-03

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
OXYCELL (N5798/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-07-24
OXYCEL OXIDIZED (N5798/S005)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
OXYCELL (N5798/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
MINI BALLOON (P780011/S012)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-30
MINI BALLOON (P780011/S011)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-18
MINI BALLOON (P780011/S010)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-01-29
MINI BALLOON (P780011/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-01-23
BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-11-05