FDA 510(k) FDA class 1 Substantially Equivalent 🇲🇽 Mexico

SALMONELLA IFA*

K Number: K885114 · Decision Aug 15, 1989
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
0
Applicant Total
24
Review Days
246

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Basic Information

Device Name
SALMONELLA IFA*
K Number
K885114
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
864.6700
Medical Specialty
Hematology
Decision
Substantially Equivalent
Applicant
Investigacion Farmaceutica S.A. DE C.V.
Date Received
December 12, 1988
Decision Date
August 15, 1989
Product Code
GHC
Advisory Committee
Hematology
Review Advisory Committee
MI
Third Party
N

Classifications

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

Product Code Device Name
GHC Tube, Sedimentation Rate

Other Clearances by Investigacion Farmaceutica S.A. DE C.V.

K Number Device Name
K892721 IFA SENSIBAC CEFACLOR
K892728 IFA SENSIBAC NORFLOXACIN
K892733 IFA SENSIBAC KANAMYCIN
K892713 IFA SENSIBAC NALIDIXIC ACID
K892735 IFA SENSIBAC CEPHALOTIN
K892726 IFA SENSIBAC PENICILLIN
K885112 BRUCELLA IFA*
K892720 IFA SENSIBAC GENTAMYCIN
K885113 IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL
K885110 PROTEUS OX-19 IFA*
Search all 24 clearances from Investigacion Farmaceutica S.A. DE C.V. →