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510(k) K862089

V-MARC 88A COMPUTER by V.Marc, A Div. of Pictorial, Inc. — Product Code KQH

K862089 is an FDA 510(k) premarket notification submitted by V.Marc, A Div. of Pictorial, Inc. for the device "V-MARC 88A COMPUTER". The FDA issued a decision of Substantially Equivalent on July 10, 1986. The device falls under product code KQH (Red-Cell Indices), a Class II device regulated under 21 CFR 864.5300. V.Marc, A Div. of Pictorial, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1986
Date Received
June 2, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Red-Cell Indices
Device Class
Class II
Regulation Number
864.5300
Review Panel
HE
Submission Type

Other clearances by V.Marc, A Div. of Pictorial, Inc.

  • K871853 — V-MARC 88A COMPUTER (July 16, 1987)

FDA data resources