Product code JCM
- Device name
- Control, Hemoglobin, Abnormal
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.7415
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K053031 | EXTENDSURE HBFASC CONTROL | Cantebury Scientific , Ltd. | 2005-12-07 |
| K011389 | HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) | Canterbury Health Laboratories | 2001-06-21 |
| K983704 | MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE | Roche Diagnostic Systems, Inc. | 1999-02-10 |
| K942222 | QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS | Isolab, Inc. | 1995-01-20 |
| K933086 | AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 | Helena Laboratories | 1994-10-31 |
| K931234 | HEMOCARD CONTROL HB-AA, AE, FAA, FAE | Isolab, Inc. | 1993-05-11 |
| K924173 | HEMOCARD(TM) CONTROL | Isolab, Inc. | 1992-12-01 |
| K913427 | SICKLE HEMOGLOBIN (HBA/S) CONTROL SET | Creative Laboratory Products, Inc. | 1991-11-19 |
| K911347 | LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL | Bio-Rad | 1991-06-10 |
| K910431 | HEMOCARD CONTROL | Isolab, Inc. | 1991-03-11 |
| K820787 | HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL | Helena Laboratories | 1982-04-08 |
| K820037 | SICKLE-CHECK | Diagnostic Technology, Inc. | 1982-02-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03607360047576 | CAPI 3 NEONAT Hb AF Control | SEBIA | 2024-04-30 |
| 03607360047927 | Hb AFSC Control | SEBIA | 2024-04-30 |
| 03607360047583 | Hb AFSA2 CONTROL (1) | SEBIA | 2023-07-27 |
| 03607360047590 | Hb AFSA2 CONTROL (5) | SEBIA | 2023-07-27 |
| 06438147385478 | RESOLVE Hb FACS Control kit | Wallac Oy | 2023-04-17 |
| B115ABCARD11371 | Advin Multi-Drug Screen Test | ADVIN BIOTECH, INC. | 2021-12-17 |
| 09421902348051 | Tosoh US | CANTERBURY SCIENTIFIC LIMITED | 2018-11-02 |
| 09421902348105 | Tosoh EU | CANTERBURY SCIENTIFIC LIMITED | 2018-11-02 |
| 09421902348020 | ExtendSURE | CANTERBURY SCIENTIFIC LIMITED | 2018-09-20 |
| 09421902348037 | ExtendSURE | CANTERBURY SCIENTIFIC LIMITED | 2018-09-20 |
| 09421902348044 | ExtendSURE | CANTERBURY SCIENTIFIC LIMITED | 2018-09-20 |
| 00847661002093 | Lyphochek | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847661000884 | Lyphochek | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| M52553390 | Normal HbA2 Quik Column Control | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52553330 | Abnormal HbA2 Quik Column Control | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| 05391516744393 | Trinity Biotech | PRIMUS CORPORATION | 2016-09-06 |
| 05391516744409 | Trinity Biotech | PRIMUS CORPORATION | 2016-09-06 |
| 05391516748315 | Trinity Biotech | PRIMUS CORPORATION | 2016-09-06 |
| 05391516748322 | Trinity Biotech | PRIMUS CORPORATION | 2016-09-06 |