MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT
FDA 510(k) clearance K861379 · decided 1986-07-16
Clearance details
- K-number
- K861379
- Device name
- MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT
- Applicant
- Serono Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-04-14
- Decision date
- 1986-07-16
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- LKT
- Device class
- 1
- Regulation number
- 866.3480
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Norwell, MA, 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 |
|---|---|---|
| D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT (K081928) | Diagnostic Hybrids, Inc. | 2008-12-23 |
| PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 (K983336) | Diagnostic Products Corp. | 1999-03-18 |
| PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV) (K943317) | Diagnostic Products Corp. | 1994-12-19 |
| RSV ANTIGEN TEST (K942173) | Neogenex | 1994-06-30 |
| RSV-MAB TEST (K912842) | Gull Laboratories, Inc. | 1991-12-09 |
| BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO (K912838) | Baxter Diagnostics, Inc. | 1991-09-27 |
| BIOMERIEUX RSV DIRECT IF KIT (K912371) | Vitek Systems, Inc. | 1991-09-23 |
| RESPIRATORY SYNCYTIAL VIRUS (K894623) | Bion Ent., Ltd. | 1989-10-16 |
| RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION (K884192) | Baxter Diagnostics, Inc. | 1988-11-22 |
| ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST (K882687) | Gull Laboratories, Inc. | 1988-08-30 |
| GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES (K873564) | Genetic Systems Corp. | 1987-11-20 |
| RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL (K872701) | Sita, Inc. | 1987-09-18 |
Recalls involving this device
No recalls on record reference this clearance.