Atlas FDA

QCA ENZYMATIC CHOLESTEROL

FDA 510(k) clearance K853871 · decided 1985-10-04

Clearance details

K-number
K853871
Device name
QCA ENZYMATIC CHOLESTEROL
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Decision
Substantially Equivalent
Date received
1985-09-17
Decision date
1985-10-04
Days to decision
17 days
Clearance type
Traditional
Product code
CHH
Device class
1
Regulation number
862.1175
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Paramus, NJ, US
Third-party review
No
Expedited review
No

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Cholesterol (K150654)Randox Laboratories, Ltd.2015-09-29
AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL (K132031)Axis-Shield Poc AS2014-03-21
PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM (K130200)Abaxis, Inc.2013-02-15
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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