The following data is part of a premarket notification filed by Helps Products, Inc. with the FDA for Microhematocrit Tubes, Heparin & Microhema Tube,pl.
| Device ID | K881186 |
| 510k Number | K881186 |
| Device Name: | MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL |
| Classification | Hematocrit, Tube, Rack, Sealer, Holder |
| Applicant | HELPS PRODUCTS, INC. 4469 S.W.35TH.STREET Orlando, FL 32811 |
| Contact | Brian Lemay |
| Correspondent | Brian Lemay HELPS PRODUCTS, INC. 4469 S.W.35TH.STREET Orlando, FL 32811 |
| Product Code | GHY |
| CFR Regulation Number | 864.6400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-21 |
| Decision Date | 1988-05-13 |