MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL
FDA 510(k) clearance K961042 · decided 1996-05-30
Clearance details
- K-number
- K961042
- Device name
- MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL
- Applicant
- Dade Microscan, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-03-14
- Decision date
- 1996-05-30
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- LRH
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- West Sacramento, CA, 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 |
|---|---|---|
| GRAM NEGATIVE IDENTIFICATION PLUS CARD (K962609) | Biomerieux Vitek, Inc. | 1996-08-30 |
| READER (K926248) | Alamar Biosciences Laboratory, Inc. | 1994-05-17 |
| AUTOSCEPTOR IDENTIFICATION SYSTEM (K920225) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-05-22 |
Recalls involving this device
No recalls on record reference this clearance.