COLOR VUE TM- MYCOPLASMA PNEUMONIAE
FDA 510(k) clearance K910833 · decided 1991-06-24
Clearance details
- K-number
- K910833
- Device name
- COLOR VUE TM- MYCOPLASMA PNEUMONIAE
- Applicant
- Seradyn, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-02-27
- Decision date
- 1991-06-24
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- GSA
- Device class
- 1
- Regulation number
- 866.3375
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Indianapolis, IN, 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 |
|---|---|---|
| MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM (K950073) | Shared Systems, Inc. | 1995-10-17 |
| MERISTAR-MP (K905493) | Meridian Diagnostics, Inc. | 1991-01-30 |
| SEROFAST (K903958) | Intl. Mycoplasma/Mdc Assoc. | 1990-12-21 |
| MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM (K883083) | Medical Diagnostic Technologies, Inc. | 1988-10-25 |
| MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM (K862630) | Medical Diagnostic Technologies, Inc. | 1986-09-03 |
Recalls involving this device
No recalls on record reference this clearance.