510(k) K981867
- Device
- IS-VZU IGG TEST SYSTEM
- Applicant
- DIAMEDIX CORP.
- 510(k) number
- K981867
- Product code
- LFY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-09-28
- Date received
- 1998-05-28
- Regulation
- 866.3900
- Classification name
- Enzyme Linked Immunoabsorbent Assay, Varicella-zoster
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LYNN STIRLING
- Address
- 2140 N. Miami Ave. Miami FL US 33127 33127
FDA Registration Numbers#
- 3002800697
- 9610240
- 3007208259
- 8020790
- 1318354
- 2242436
- 2029372
- 2245285
- 1641328
- 3032705
- 2915274
Source Documents#
Other 510(k) Records For Product Code LFY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231214 | LIAISON VZV IgG HT, LIAISON Control VZV IgG HT | DiaSorin, Inc. | 2023-10-27 |
| K150375 | LIAISON VZV IgG, LIAISON Control VZV IgG | DiaSorin, Inc. | 2015-03-11 |
| K070317 | ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM | Zeus Scientific, Inc. | 2007-07-05 |
| K061820 | DIASORIN LIAISON VZV IGG | DiaSorin, Inc. | 2007-02-26 |
| K051484 | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. | Zeus Scientific, Inc. | 2005-12-05 |
| K984181 | THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1999-01-22 |
| K972295 | SERAQUEST VZV IGG | Quest Intl., Inc. | 1997-11-05 |
| K961012 | VZV IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1996-07-24 |
| K943843 | VARICELISA, MODIFICATION | Biowhittaker Molecular Applications, Inc. | 1996-03-14 |
| K941046 | VZV IGG ELISA TEST | Gull Laboratories, Inc. | 1995-08-24 |
| K923122 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | Biomerieux Vitek, Inc. | 1992-10-26 |
| K914022 | SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS | Pharmacia Diagnostics, Inc. | 1992-01-27 |
| K900688 | VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT | Clinical Sciences, Inc. | 1990-05-15 |
| K890642 | VZV MICROASSAY | Diamedix Corp. | 1989-05-15 |
| K833637 | VZV BIO-ENZABEAD SCREEN KIT | Bionetic Laboratory Products | 1984-02-10 |
Legacy Summary#
summary
FDA Review#
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