HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM
FDA 510(k) clearance K983656 · decided 1999-03-18
Clearance details
- K-number
- K983656
- Device name
- HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM
- Applicant
- Zeus Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-10-19
- Decision date
- 1999-03-18
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- LGC
- Device class
- 2
- Regulation number
- 866.3305
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Branchburg, NJ, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| HERPES GROUP IGG (K033059) | Trinity Biotech, Inc. | 2003-11-26 |
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| POCKIT HSV 2 RAPID TEST (K983886) | Diagnology , Ltd. | 1999-08-19 |
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| DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM (K981306) | Diamedix Corp. | 1998-09-29 |
| HERPES GROUP IGG ELISA TEST SYSTEM (K963645) | Armkel, LLC | 1997-02-04 |
| SERAQUEST HSV IGG (K963282) | Quest Intl., Inc. | 1997-01-22 |
| IMMULITE HERPES I AND II IGG (K950670) | Diagnostic Products Corp. | 1996-06-21 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM (P150042) | Zeus Scientific, Inc. | 2017-09-19 |
| ZEUS ELISA PARVOVIRUS B19 IGG TEST SYSTEM (P150045) | Zeus Scientific, Inc. | 2017-09-19 |
| FLUORO-CEP (R) PROGESTERONE (P900025/S001) | Zeus Scientific, Inc. | 1992-04-21 |
| FLUORO-CEP (R) PROGESTERONE (P900025/S002) | Zeus Scientific, Inc. | 1992-04-17 |
| FLUORO-CEP (R) PROGESTERONE (P900025) | Zeus Scientific, Inc. | 1990-09-26 |