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

CELL COUNTING GRID GRATICULE

K Number: K874190 · Decision Jan 5, 1988
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
8
Applicant Total
9
Review Days
83

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Basic Information

Device Name
CELL COUNTING GRID GRATICULE
K Number
K874190
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
864.3600
Medical Specialty
Pathology
Decision
Substantially Equivalent
Applicant
Portable Medical Laboratories, Inc.
Date Received
October 14, 1987
Decision Date
January 5, 1988
Product Code
IBJ
Advisory Committee
Pathology
Review Advisory Committee
HE
Third Party
N

Classifications

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

Product Code Device Name
IBJ Light, Microscope

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Other Clearances by Portable Medical Laboratories, Inc.

K Number Device Name
K882101 HEMOGLOBIN SCREENING DEVICE
K871671 URINOSCOPY FUNNEL
K864049 MCARTHUR MICROSCOPE, STANDARD METAL VERSION
K854735 MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC.
K844476 PORTABLE DIAGNOSTIC LABORATORY
K844475 SPECIMEN COLLECTION & TRANSPORT SYSTEM
K844442 RAPID DIAGNOSTIC KIT
K844473 HAND-HELD SLIDE READER