The following data is part of a premarket notification filed by Caltag Laboratories, Inc. with the FDA for Caltag Fetal Hemoglobin Test.
| Device ID | K990641 |
| 510k Number | K990641 |
| Device Name: | CALTAG FETAL HEMOGLOBIN TEST |
| Classification | Stain, Fetal Hemoglobin |
| Applicant | CALTAG LABORATORIES, INC. 605 DILWORTH RD. Downingtown, PA 19335 |
| Contact | David C Bishop |
| Correspondent | David C Bishop CALTAG LABORATORIES, INC. 605 DILWORTH RD. Downingtown, PA 19335 |
| Product Code | GHQ |
| CFR Regulation Number | 864.7455 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-26 |
| Decision Date | 1999-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10190302005609 | K990641 | 000 |
| 10190302005593 | K990641 | 000 |
| 10190302005586 | K990641 | 000 |
| 10190302005579 | K990641 | 000 |
| 10190302005340 | K990641 | 000 |
| 10190302005333 | K990641 | 000 |