The following data is part of a premarket notification filed by Swemed Lab International Ab with the FDA for Blastomere Biopsy Pipette, Models H-55530 And H-55540.
| Device ID | K022643 |
| 510k Number | K022643 |
| Device Name: | BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 |
| Classification | Microtools, Assisted Reproduction (pipettes) |
| Applicant | SWEMED LAB INTERNATIONAL AB 555 13TH ST. N.W. Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein SWEMED LAB INTERNATIONAL AB 555 13TH ST. N.W. Washington, DC 20004 |
| Product Code | MQH |
| CFR Regulation Number | 884.6130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-08 |
| Decision Date | 2002-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17350025912117 | K022643 | 000 |
| 17350025912049 | K022643 | 000 |
| 17350025911998 | K022643 | 000 |