RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY
FDA 510(k) clearance K922801 · decided 1993-01-06
Clearance details
- K-number
- K922801
- Device name
- RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY
- Applicant
- Light Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1992-06-10
- Decision date
- 1993-01-06
- Days to decision
- 210 days
- Clearance type
- Traditional
- Product code
- GNY
- Device class
- 1
- Regulation number
- 866.3020
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Temecula, 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 |
|---|---|---|
| MURINE MONOCLONAL ANTI-ADENOVIRUS IGG (K885310) | Whittaker Bioproducts, Inc. | 1989-02-16 |
| ADENOVIRUS GROUP-FA LABELLED PRESERUM (K770811) | Flow Laboratories, Inc. | 1977-05-20 |
| ADENOVIRUS-GROUP FA LABELLED (8-651 RF) (K770807) | Flow Laboratories, Inc. | 1977-05-20 |
Recalls involving this device
No recalls on record reference this clearance.