The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Sickle-chex Solubility Kit.
| Device ID | K023656 |
| 510k Number | K023656 |
| Device Name: | SICKLE-CHEX SOLUBILITY KIT |
| Classification | Test, Sickle Cell |
| Applicant | STRECK LABORATORIES, INC. 7002 SOUTH 109TH ST. La Vista, NE 68128 |
| Contact | Carol Thompson |
| Correspondent | Carol Thompson STRECK LABORATORIES, INC. 7002 SOUTH 109TH ST. La Vista, NE 68128 |
| Product Code | GHM |
| CFR Regulation Number | 864.7825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-30 |
| Decision Date | 2002-12-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844509002048 | K023656 | 000 |
| 00844509002031 | K023656 | 000 |
| 00844509002024 | K023656 | 000 |