AMIZYME-HSV TYPES 1 & 2 TEST KITS
FDA 510(k) clearance K842531 · decided 1985-12-06
Clearance details
- K-number
- K842531
- Device name
- AMIZYME-HSV TYPES 1 & 2 TEST KITS
- Applicant
- Amico Lab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-06-28
- Decision date
- 1985-12-06
- Days to decision
- 526 days
- Clearance type
- Traditional
- Product code
- GQO
- Device class
- 2
- Regulation number
- 866.3305
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- TN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VIRGO HSV-2 IGG ELISA (K883281) | Electro-Nucleonics, Inc. | 1989-03-10 |
| VIRGO HSV-1 IGG ELISA (K883282) | Electro-Nucleonics, Inc. | 1989-03-10 |
| BION HSV1-G OR HSV2-G TEST SYSTEM (K881261) | Bion Ent., Ltd. | 1988-06-07 |
| THE DDI SERODOT HERPES IGG TEST KIT (K875366) | Disease Detection International, Inc. | 1988-05-23 |
| VIROGEN HSV ANTIBODY TEST (K871426) | Armkel, LLC | 1987-10-15 |
| THE GOLDEN QUAD TEST (HSV) (K861120) | Microbiological Research Corp. | 1987-02-02 |
| VISIBLE-HERPES TM TEST SYSTEM (K854712) | Isolab, Inc. | 1986-05-20 |
| HSVI - IGG ELISA-KIT (K852782) | Clinical Sciences, Inc. | 1986-01-21 |
| HSV2 - IGG ELISA-KIT (K852781) | Clinical Sciences, Inc. | 1986-01-21 |
| ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 (K842663) | Amico Lab, Inc. | 1985-12-06 |
| HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT (K852931) | Microbix Biosystems, Inc. | 1985-11-12 |
| ENZYGNOST ANTIHERPES SIMPLEX VIRUS (K841245) | Behring Diagnostics, Inc. | 1985-11-05 |
Recalls involving this device
No recalls on record reference this clearance.