The following data is part of a premarket notification filed by V.marc, A Div. Of Pictorial, Inc. with the FDA for V-marc 88a Computer.
| Device ID | K862089 |
| 510k Number | K862089 |
| Device Name: | V-MARC 88A COMPUTER |
| Classification | Red-cell Indices |
| Applicant | V.MARC, A DIV. OF PICTORIAL, INC. 8081 ZIONSVILLE RD. BOX 68886 Indianapolis, IN 46268 |
| Contact | James M Connolly |
| Correspondent | James M Connolly V.MARC, A DIV. OF PICTORIAL, INC. 8081 ZIONSVILLE RD. BOX 68886 Indianapolis, IN 46268 |
| Product Code | KQH |
| CFR Regulation Number | 864.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-02 |
| Decision Date | 1986-07-10 |