Atlas FDA

LATELET RETENTION COLUMN

FDA 510(k) clearance K771523 · decided 1977-11-22

Clearance details

K-number
K771523
Device name
LATELET RETENTION COLUMN
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Decision
Substantially Equivalent
Date received
1977-08-08
Decision date
1977-11-22
Days to decision
106 days
Clearance type
Traditional
Product code
JBZ
Device class
2
Regulation number
864.6650
Medical specialty
Hematology
Advisory committee
Hematology
Location
Washington, DC, 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
PLATELET RETENTION (ADHESION) COLUMNS (K800037)Hemometrix1980-02-05
THROMBO-SCREEN PLATELET ADHESION (K771678)Bay Area Hema. Onco. Clinic. & Res. L1977-11-22

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