FDA Product Code
FDA Product Code JCM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7415
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K053031 | EXTENDSURE HBFASC CONTROL | Cantebury Scientific , Ltd. | 2005-12-07 | Traditional | PDF ↗ |
| K011389 | HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) | Canterbury Health Laboratories | 2001-06-21 | Traditional | PDF ↗ |
| K983704 | MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE | Roche Diagnostic Systems, Inc. | 1999-02-10 | Traditional | PDF ↗ |
| K942222 | QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS | Isolab, Inc. | 1995-01-20 | Traditional | PDF ↗ |
| K933086 | AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 | Helena Laboratories | 1994-10-31 | Traditional | PDF ↗ |
| K931234 | HEMOCARD CONTROL HB-AA, AE, FAA, FAE | Isolab, Inc. | 1993-05-11 | Traditional | PDF ↗ |
| K924173 | HEMOCARD(TM) CONTROL | Isolab, Inc. | 1992-12-01 | Traditional | PDF ↗ |
| K913427 | SICKLE HEMOGLOBIN (HBA/S) CONTROL SET | Creative Laboratory Products, Inc. | 1991-11-19 | Traditional | PDF ↗ |
| K911347 | LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL | Bio-Rad | 1991-06-10 | Traditional | PDF ↗ |
| K910431 | HEMOCARD CONTROL | Isolab, Inc. | 1991-03-11 | Traditional | PDF ↗ |
| K820787 | HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL | Helena Laboratories | 1982-04-08 | Traditional | PDF ↗ |
| K820037 | SICKLE-CHECK | Diagnostic Technology, Inc. | 1982-02-04 | Traditional | PDF ↗ |
Product code JCM · Class II · Hematology. Data: openFDA.