The following data is part of a premarket notification filed by Wortham Laboratories Inc with the FDA for Stasis - I, Ii And Iii; Serathan - A, B; Intrin - Ea, Si Calcium Chloride 0.02m; Fibrinogen Control-normal, Low.
| Device ID | K060968 |
| 510k Number | K060968 |
| Device Name: | STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW |
| Classification | Plasma, Control, Normal |
| Applicant | WORTHAM LABORATORIES INC 6340 BONNY OAKS DR. Chattanooga, TN 37416 |
| Contact | Leon Wortham |
| Correspondent | Leon Wortham WORTHAM LABORATORIES INC 6340 BONNY OAKS DR. Chattanooga, TN 37416 |
| Product Code | GIZ |
| Subsequent Product Code | GFO |
| Subsequent Product Code | GGC |
| Subsequent Product Code | GGN |
| Subsequent Product Code | GIL |
| Subsequent Product Code | GJS |
| Subsequent Product Code | KQJ |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-07 |
| Decision Date | 2007-05-15 |
| Summary: | summary |