JCM
12 FDA 510(k) clearances · Product code
75 daysmedian time to decision
259 days90th percentile
12clearances measured
FDA profile
- Official device name
- Control, Hemoglobin, Abnormal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7415
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 2005: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| EXTENDSURE HBFASC CONTROL (K053031) | Cantebury Scientific , Ltd. | 2005-12-07 |
| HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) (K011389) | Canterbury Health Laboratories | 2001-06-21 |
| MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE (K983704) | Roche Diagnostic Systems, Inc. | 1999-02-10 |
| QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS (K942222) | Isolab, Inc. | 1995-01-20 |
| AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 (K933086) | Helena Laboratories | 1994-10-31 |
| HEMOCARD CONTROL HB-AA, AE, FAA, FAE (K931234) | Isolab, Inc. | 1993-05-11 |
| HEMOCARD(TM) CONTROL (K924173) | Isolab, Inc. | 1992-12-01 |
| SICKLE HEMOGLOBIN (HBA/S) CONTROL SET (K913427) | Creative Laboratory Products, Inc. | 1991-11-19 |
| LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL (K911347) | Bio-Rad | 1991-06-10 |
| HEMOCARD CONTROL (K910431) | Isolab, Inc. | 1991-03-11 |
| HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL (K820787) | Helena Laboratories | 1982-04-08 |
| SICKLE-CHECK (K820037) | Diagnostic Technology, Inc. | 1982-02-04 |
Track JCM automatically
Every clearance here is in the API, with alerts when new ones post.