510(k) K841245
- Device
- Enzygnost Antiherpes Simplex Virus
- Applicant
- BEHRING DIAGNOSTICS, INC.
- 510(k) number
- K841245
- Product code
- GQO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-11-05
- Date received
- 1984-03-23
- Regulation
- 866.3305
- Classification name
- Antisera, Cf, Herpesvirus Hominis 1,2
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- La Jolla CA US 92037 92037
FDA Registration Numbers#
- 1318354
- 2032682
- 2029372
- 1419968
- 3004973408
- 1181055
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GQO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K883281 | VIRGO HSV-2 IGG ELISA | Electro-Nucleonics, Inc. | 1989-03-10 |
| K883282 | VIRGO HSV-1 IGG ELISA | Electro-Nucleonics, Inc. | 1989-03-10 |
| K881261 | BION HSV1-G OR HSV2-G TEST SYSTEM | Bion Ent., Ltd. | 1988-06-07 |
| K875366 | THE DDI SERODOT HERPES IGG TEST KIT | Disease Detection International, Inc. | 1988-05-23 |
| K871426 | VIROGEN HSV ANTIBODY TEST | Armkel, LLC | 1987-10-15 |
| K861120 | THE GOLDEN QUAD TEST (HSV) | Microbiological Research Corp. | 1987-02-02 |
| K854712 | VISIBLE-HERPES TM TEST SYSTEM | Isolab, Inc. | 1986-05-20 |
| K852781 | HSV2 - IGG ELISA-KIT | Clinical Sciences, Inc. | 1986-01-21 |
| K852782 | HSVI - IGG ELISA-KIT | Clinical Sciences, Inc. | 1986-01-21 |
| K842531 | AMIZYME-HSV TYPES 1 & 2 TEST KITS | Amico Lab, Inc. | 1985-12-06 |
| K842663 | ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 | Amico Lab, Inc. | 1985-12-06 |
| K852931 | HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT | Microbix Biosystems, Inc. | 1985-11-12 |
| K852928 | VIROGEN HERPES SLIDE TEST | Armkel, LLC | 1985-10-17 |
| K842887 | HERPES VIRUS AGGLUTINATION TEST | Scientific Research | 1985-02-26 |
| K791058 | ANTIBODY TO HERPESVIRUS HOMINIS | Electro-Nucleonics Laboratories, Inc. | 1979-09-07 |