VZV IGG ELISA TEST
FDA 510(k) clearance K941046 · decided 1995-08-24
Clearance details
- K-number
- K941046
- Device name
- VZV IGG ELISA TEST
- Applicant
- Gull Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-03-07
- Decision date
- 1995-08-24
- Days to decision
- 535 days
- Clearance type
- Traditional
- Product code
- LFY
- Device class
- 2
- Regulation number
- 866.3900
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| 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 |
| VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (K923122) | Biomerieux Vitek, Inc. | 1992-10-26 |
| SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS (K914022) | Pharmacia Diagnostics, Inc. | 1992-01-27 |
Recalls involving this device
No recalls on record reference this clearance.