The following data is part of a premarket notification filed by Zenyx Scientific Ltd. with the FDA for Quatro Sp Sample Processing Systems (200-499, Inclusive).
| Device ID | K973335 |
| 510k Number | K973335 |
| Device Name: | QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE) |
| Classification | Station, Pipetting And Diluting, For Clinical Use |
| Applicant | ZENYX SCIENTIFIC LTD. BARNES HOSPITAL Cheadle, Cheshire, GB Skb 2ny |
| Contact | Paul W Mcwalter |
| Correspondent | Paul W Mcwalter ZENYX SCIENTIFIC LTD. BARNES HOSPITAL Cheadle, Cheshire, GB Skb 2ny |
| Product Code | JQW |
| CFR Regulation Number | 862.2750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-04 |
| Decision Date | 1998-04-30 |
| Summary: | summary |