EBV TEST
FDA 510(k) clearance K771062 · decided 1977-07-14
Clearance details
- K-number
- K771062
- Device name
- EBV TEST
- Applicant
- Gull Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-06-13
- Decision date
- 1977-07-14
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- GNP
- Device class
- 1
- Regulation number
- 866.3235
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- UT, 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 |
|---|---|---|
| EBV V VCA IGM ELISA KIT MODEL# EBM-200 (K020717) | Pan Bio Pty. , Ltd. | 2002-06-13 |
| EBV-VCA IGG ELISA TEST, MODEL EBG-100 (K020706) | Pan Bio Pty. , Ltd. | 2002-06-13 |
| EBV-EBNA IGG ELISA KIT, MODEL EBG-100 (K020707) | Pan Bio Pty. , Ltd. | 2002-06-13 |
| IS EBV-EA-D IGG ELISA TEST SYSTEM (K981831) | Diamedix Corp. | 1999-02-16 |
| IS EBV-EBNA-1 IGG ELISA TEST SYSTEM (K981829) | Diamedix Corp. | 1999-02-16 |
| EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM (K901156) | Granbio, Inc. | 1990-09-12 |
| SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI (K883670) | Electro-Nucleonics, Inc. | 1989-04-28 |
| EBV-VCA ANTIBODY (IGG) (K884591) | Hillcrest Biologicals | 1989-01-24 |
| EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) (K880885) | Immuno Concepts, Inc. | 1988-08-30 |
| EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT) (K880883) | Immuno Concepts, Inc. | 1988-08-30 |
| EBV-CHECK(TM) TEST KIT (IGG) (K871373) | Diagnostic Technology, Inc. | 1987-06-25 |
| THE GOLDEN QUAD TEST (EBV) (K861121) | Microbiological Research Corp. | 1987-02-02 |
Recalls involving this device
No recalls on record reference this clearance.