HERPTRAN CONCENTRATE
FDA 510(k) clearance K900713 · decided 1990-05-11
Clearance details
- K-number
- K900713
- Device name
- HERPTRAN CONCENTRATE
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-02-14
- Decision date
- 1990-05-11
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- LGC
- Device class
- 2
- Regulation number
- 866.3305
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Wilmington, DE, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch E.I. Dupont DE Nemours & Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HERPES GROUP IGG (K033059) | Trinity Biotech, Inc. | 2003-11-26 |
| MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6 (K010878) | Diagnostic Products Corp. | 2001-04-18 |
| DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM (K002262) | Diamedix Corp. | 2000-11-28 |
| HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G (K000238) | Mrl Diagnostics | 2000-04-14 |
| THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR (K992166) | Zeus Scientific, Inc. | 1999-09-03 |
| POCKIT HSV 2 RAPID TEST (K983886) | Diagnology , Ltd. | 1999-08-19 |
| PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST (K984346) | Meridian Diagnostics, Inc. | 1999-06-25 |
| HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM (K983656) | Zeus Scientific, Inc. | 1999-03-18 |
| HSV 1+2 IGG ELISA TEST (K983541) | Gull Laboratories, Inc. | 1999-02-26 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.