REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS
FDA 510(k) clearance K812741 · decided 1981-10-23
Clearance details
- K-number
- K812741
- Device name
- REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS
- Applicant
- Nolan Biological Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-09-29
- Decision date
- 1981-10-23
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- LHK
- Device class
- 2
- Regulation number
- 866.3165
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST (K893753) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-16 |
| CANDIDA DETECTION SYSTEM (K823016) | Ramco Laboratories, Inc. | 1982-12-28 |
| CANDIDA IMMUNODIFFUSION SYSTEM (K812186) | American Scientific Products | 1981-08-25 |
Recalls involving this device
No recalls on record reference this clearance.