Atlas FDA

QCA TRIGLYCERIDES

FDA 510(k) clearance K842891 · decided 1984-08-22

Clearance details

K-number
K842891
Device name
QCA TRIGLYCERIDES
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Decision
Substantially Equivalent
Date received
1984-07-23
Decision date
1984-08-22
Days to decision
30 days
Clearance type
Traditional
Product code
CDT
Device class
1
Regulation number
862.1705
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
Triglycerides (K150819)Randox Laboratories Limited2015-08-06
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT (K133067)Siemens Healthcare Diagnostics, Inc.2013-11-22
VITROS CHEMISTRY PRODUCTS TRIG SLIDES (K130332)Ortho-Clinical Diagnostics, Inc.2013-05-31
VANTERA CLINICAL ANALYZER (K113830)Liposcience2012-08-30
ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL (K102993)Seppim S.A.S.2011-05-19
OLYMPUS TRIGLYCERIDE TEST SYSTEM (K063804)Olympus America, Inc.2007-03-23
DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE (K043546)Dade Behring, Inc.2005-01-18
VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR (K034000)Clinical Data, Inc.2004-03-10
CARESIDE TRGLYCERIDE (K020488)Careside, Inc.2002-04-15
TGL FLEX REAGENT CARTRIDGE (K010871)Dade Behring, Inc.2001-07-09
WAKO L-TYPE TRIGLYCERIDE TEST (K993466)Wako Chemicals USA, Inc.1999-11-09
TRIGLYCERIDES, TG, OR TRIG (K971324)Carolina Liquid Chemistries Corp.1997-06-20

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