FRESHFROZEN CELLS, HEP-2
FDA 510(k) clearance K962782 · decided 1996-08-29
Clearance details
- K-number
- K962782
- Device name
- FRESHFROZEN CELLS, HEP-2
- Applicant
- Diagnostic Hybrids, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-07-17
- Decision date
- 1996-08-29
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- KIR
- Device class
- 1
- Regulation number
- 864.2280
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Athens, OH, 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 |
|---|---|---|
| FRESH CELLS WI-38 (K973212) | Diagnostic Hybrids, Inc. | 1997-09-25 |
| FRESH CELLS MV1LU (K973211) | Diagnostic Hybrids, Inc. | 1997-09-25 |
| FRESH CELLS NCI H292 (K973210) | Diagnostic Hybrids, Inc. | 1997-09-25 |
| FRESH CELLS VERO (K973209) | Diagnostic Hybrids, Inc. | 1997-09-25 |
| FRESH CELLS HFF (K973214) | Diagnostic Hybrids, Inc. | 1997-09-25 |
| FRESH CELLS LLC-MK2 (K973213) | Diagnostic Hybrids, Inc. | 1997-09-25 |
| RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE (K971508) | Bio-Whittaker, Inc., A Cambrex Co. | 1997-09-17 |
| FRESHCELLS (K972414) | Diagnostic Hybrids, Inc. | 1997-08-29 |
| MINK LUNG CELL CULTURE (K965047) | Neogenex | 1997-02-04 |
| FRESHFROZENCELLS (K962311) | Diagnostic Hybrids, Inc. | 1996-08-29 |
| FRESHCELLS, HEP-2 (K962780) | Diagnostic Hybrids, Inc. | 1996-08-29 |
| FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES (K962306) | Diagnostic Hybrids, Inc. | 1996-08-29 |
Recalls involving this device
No recalls on record reference this clearance.