510(k) K910431
- Device
- HEMOCARD CONTROL
- Applicant
- ISOLAB, INC.
- 510(k) number
- K910431
- Product code
- JCM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-03-11
- Date received
- 1991-02-01
- Regulation
- 864.7415
- Classification name
- Control, Hemoglobin, Abnormal
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JANET D PERKINS
- Address
- Drawer 4350 Akron OH US 44321 44321
FDA Registration Numbers#
- 3003982601
- 3014150341
- 8023024
- 8043909
- 3010127294
- 2016706
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JCM #
| 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 |
| K820787 | HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL | Helena Laboratories | 1982-04-08 |
| K820037 | SICKLE-CHECK | Diagnostic Technology, Inc. | 1982-02-04 |
Legacy Summary#
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FDA Review#
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