Panels › Hematology › Product code JCM · Class 2
Control, Hemoglobin, Abnormal
Regulation 864.7415
0510(k)s in 12 months (12 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in JCM
| Company | 510(k)s | Recalls |
|---|---|---|
| Isolab, Inc. | 4 | 0 |
| Helena Laboratories | 2 | 0 |
| Bio-Rad | 1 | 0 |
| Cantebury Scientific , Ltd. | 1 | 0 |
| Canterbury Health Laboratories | 1 | 0 |
| Creative Laboratory Products, Inc. | 1 | 0 |
| Diagnostic Technology, Inc. | 1 | 0 |
| Roche Diagnostic Systems, Inc. | 1 | 0 |
| Tosoh Bioscience, Inc. | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 7, 2005 | K053031 | EXTENDSURE HBFASC CONTROL Cantebury Scientific , Ltd., NZ | JCM |
| Jun 21, 2001 | K011389 | HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) Canterbury Health Laboratories, NZ | JCM |
| Feb 10, 1999 | K983704 | MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE Roche Diagnostic Systems, Inc. | JCM |
| Jan 20, 1995 | K942222 | QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS Isolab, Inc. | JCM |
| Oct 31, 1994 | K933086 | AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 Helena Laboratories | JCM |
| May 11, 1993 | K931234 | HEMOCARD CONTROL HB-AA, AE, FAA, FAE Isolab, Inc. | JCM |
| Dec 1, 1992 | K924173 | HEMOCARD(TM) CONTROL Isolab, Inc. | JCM |
| Nov 19, 1991 | K913427 | SICKLE HEMOGLOBIN (HBA/S) CONTROL SET Creative Laboratory Products, Inc. | JCM |
| Jun 10, 1991 | K911347 | LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL Bio-Rad | JCM |
| Mar 11, 1991 | K910431 | HEMOCARD CONTROL Isolab, Inc. | JCM |
| Apr 8, 1982 | K820787 | HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL Helena Laboratories | JCM |
| Feb 4, 1982 | K820037 | SICKLE-CHECK Diagnostic Technology, Inc. | JCM |
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