The following data is part of a premarket notification filed by Norfolk Scientific, Inc. with the FDA for Safecrit Plastic Microhematocrit Tubes.
| Device ID | K883185 |
| 510k Number | K883185 |
| Device Name: | SAFECRIT PLASTIC MICROHEMATOCRIT TUBES |
| Classification | Hematocrit, Tube, Rack, Sealer, Holder |
| Applicant | NORFOLK SCIENTIFIC, INC. 85 MORSE ST. Norwood, MA 02062 |
| Contact | Thomas Kelley |
| Correspondent | Thomas Kelley NORFOLK SCIENTIFIC, INC. 85 MORSE ST. Norwood, MA 02062 |
| Product Code | GHY |
| CFR Regulation Number | 864.6400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-28 |
| Decision Date | 1988-08-18 |