VZV BIO-ENZABEAD SCREEN KIT
FDA 510(k) clearance K833637 · decided 1984-02-10
Clearance details
- K-number
- K833637
- Device name
- VZV BIO-ENZABEAD SCREEN KIT
- Applicant
- Bionetic Laboratory Products
- Decision
- Substantially Equivalent
- Date received
- 1983-10-17
- Decision date
- 1984-02-10
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- LFY
- Device class
- 2
- Regulation number
- 866.3900
- 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 |
|---|---|---|
| LIAISON VZV IgG HT, LIAISON Control VZV IgG HT (K231214) | DiaSorin, Inc. | 2023-10-27 |
| LIAISON VZV IgG, LIAISON Control VZV IgG (K150375) | DiaSorin, Inc. | 2015-03-11 |
| ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM (K070317) | Zeus Scientific, Inc. | 2007-07-05 |
| DIASORIN LIAISON VZV IGG (K061820) | DiaSorin, Inc. | 2007-02-26 |
| ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. (K051484) | Zeus Scientific, Inc. | 2005-12-05 |
| THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM (K984181) | Zeus Scientific, Inc. | 1999-01-22 |
| IS-VZU IGG TEST SYSTEM (K981867) | Diamedix Corp. | 1998-09-28 |
| SERAQUEST VZV IGG (K972295) | Quest Intl., Inc. | 1997-11-05 |
| VZV IGG ELISA TEST SYSTEM (K961012) | Zeus Scientific, Inc. | 1996-07-24 |
| VARICELISA, MODIFICATION (K943843) | Biowhittaker Molecular Applications, Inc. | 1996-03-14 |
| VZV IGG ELISA TEST (K941046) | Gull Laboratories, Inc. | 1995-08-24 |
| VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (K923122) | Biomerieux Vitek, Inc. | 1992-10-26 |
Recalls involving this device
No recalls on record reference this clearance.