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

(MSI) PATH-SAVER

K Number: K872140 · Decision Jun 15, 1987
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
14
Applicant Total
40
Review Days
13

Basic Information

Device Name
(MSI) PATH-SAVER
K Number
K872140
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
864.4010
Medical Specialty
Pathology
Decision
Substantially Equivalent
Applicant
MEDICAL SPECIALTIES, INC.
Date Received
June 2, 1987
Decision Date
June 15, 1987
Product Code
IFP
Advisory Committee
Pathology
Review Advisory Committee
PA
Third Party
N

Classifications

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

Product Code Device Name
IFP Formalin, Neutral Buffered

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K924926 MSI-HCT
K896566 MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE
K883850 MSI-CAL 16
K883703 MSI-CAL 7
K883851 MSI-CAL 8
K880608 MSI-PC
K880270 MSI-DIFF PLUS
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