CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4
FDA 510(k) clearance K961807 · decided 1996-07-26
Clearance details
- K-number
- K961807
- Device name
- CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4
- Applicant
- Ciba Corning Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-05-10
- Decision date
- 1996-07-26
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- GLK
- Device class
- 2
- Regulation number
- 864.8625
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Medfield, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EUROTROL HEMATOCRIT CONTROL (K121467) | Eurotrol B.V. | 2013-05-10 |
| MEDICA EASYQC HEMATOCRIT CONTROL (K021924) | Bionostics, Inc. | 2002-06-24 |
| AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL (K020618) | Aalto Scientific, Ltd. | 2002-05-14 |
| HEMATACHEK (K964452) | Richmond Diagnostics, Inc. | 1997-02-20 |
| MSI-HCT (K924926) | Medical Specialties, Inc. | 1993-01-07 |
| A.QC HCT LEVEL 1 AND 2 (K893562) | Johnson & Johnson Professionals, Inc. | 1989-07-14 |
Recalls involving this device
No recalls on record reference this clearance.