510(k) K002262
- Device
- DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM
- Applicant
- DIAMEDIX CORP.
- 510(k) number
- K002262
- Product code
- LGC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-11-28
- Date received
- 2000-07-25
- Regulation
- 866.3305
- Classification name
- Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LYNNE STIRLING
- Address
- 2140 N. Miami Ave. Miami FL US 33127 33127
FDA Registration Numbers#
- 2090110
- 2023365
- 3007208259
- 1318354
- 3032705
- 9610746
- 3008344661
- 2242436
- 1827821
- 2029372
- 9617136
- 3005333358
- 1641328
- 3006198300
- 3022178699
- 1036362
- 3002806944
- 2432235
Source Documents#
Other 510(k) Records For Product Code LGC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K033059 | HERPES GROUP IGG | Trinity Biotech, Inc. | 2003-11-26 |
| K010878 | MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6 | Diagnostic Products Corp. | 2001-04-18 |
| K000238 | HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G | Mrl Diagnostics | 2000-04-14 |
| K992166 | THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR | Zeus Scientific, Inc. | 1999-09-03 |
| K983886 | POCKIT HSV 2 RAPID TEST | Diagnology , Ltd. | 1999-08-19 |
| K984346 | PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST | Meridian Diagnostics, Inc. | 1999-06-25 |
| K983656 | HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1999-03-18 |
| K983541 | HSV 1+2 IGG ELISA TEST | Gull Laboratories, Inc. | 1999-02-26 |
| K981306 | DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM | Diamedix Corp. | 1998-09-29 |
| K963645 | HERPES GROUP IGG ELISA TEST SYSTEM | Armkel, LLC | 1997-02-04 |
| K963282 | SERAQUEST HSV IGG | Quest Intl., Inc. | 1997-01-22 |
| K950670 | IMMULITE HERPES I AND II IGG | Diagnostic Products Corp. | 1996-06-21 |
| K953839 | PREMIER HSV PLUS | Meridian Diagnostics, Inc. | 1996-05-23 |
| K925208 | ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION | Ortho Diagnostic Systems, Inc. | 1992-12-28 |
| K922333 | BARTELS HERPES SIMPLEX VIRUS 2 IGM EIA | Baxter Diagnostics, Inc. | 1992-12-15 |
Legacy Summary#
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FDA Review#
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