510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862089Substantially Equivalent

V-Marc 88A Computer

V.Marc, A Div. of Pictorial, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862089 is the FDA 510(k) clearance record for V-MARC 88A COMPUTER, a class II device, cleared for V.Marc, A Div. of Pictorial, Inc. on under FDA product code KQH (Red-Cell Indices). FDA records list 2 510(k) clearances for V.Marc, A Div. of Pictorial, Inc., from to . As of , FDA records show no recalls naming K862089.

Clearance record

Decision date
Received
(38 days to decision)
Product code
KQH Red-Cell Indices
Regulation
21 CFR 864.5300
Device class
Class II
Review panel
Hematology
Applicant
V.Marc, A Div. of Pictorial, Inc. 8081 Zionsville Rd., Indianapolis IN
Third party review
No

Clearances, product code KQH

Trailing 12 months

FDA records hold no clearances under product code KQH in the trailing twelve months.

FDA records show no clearances under product code KQH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KQH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260