FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

PIPETS BOROSILICATE GLASS

K Number: K771138 · Decision Aug 4, 1977
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
3
Applicant Total
44
Review Days
41

Basic Information

Device Name
PIPETS BOROSILICATE GLASS
K Number
K771138
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
864.6160
Medical Specialty
Hematology
Decision
Substantially Equivalent
Applicant
DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
Date Received
June 24, 1977
Decision Date
August 4, 1977
Product Code
GJW
Advisory Committee
Hematology
Review Advisory Committee
CH
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
GJW Pipette, Pasteur

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (GJW), ordered by most recent decision date.

View all

Other Clearances by DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.

K Number Device Name
K800296 WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3
K792606 WHOLE BLOOD PLATELET CONTROL NORMAL,
K792723 BLOOD FLUID FILTERS
K792607 T3 UPTAKE (T3U) REAGENTS
K792443 TSH RADIOIMMUNOASSAY
K792442 FERRITIN RADIOIMMUNOASSAY
K791922 HARLECO BRAND CLINICARD LIPASE TEST SET
K792183 DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO
K790767 IMMU-TEK AUTOMATIC CENTRIFUGE
K790776 DADE LOW IONIC STRENGTH SOLUITION (LISS)
Search all 44 clearances from DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. →