The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Micro Hematocrit Capillary Tubes.
| Device ID | K843892 |
| 510k Number | K843892 |
| Device Name: | MICRO HEMATOCRIT CAPILLARY TUBES |
| Classification | Tube, Collection, Capillary Blood |
| Applicant | ABCO DEALERS, INC. 6637 NORTH SIDNEY PLACE Milwaukee , WI 53217 - |
| Contact | Piyush M Shah |
| Correspondent | Piyush M Shah ABCO DEALERS, INC. 6637 NORTH SIDNEY PLACE Milwaukee , WI 53217 - |
| Product Code | GIO |
| CFR Regulation Number | 864.6150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-03 |
| Decision Date | 1984-11-13 |