TOXO TEST
FDA 510(k) clearance K772243 · decided 1977-12-22
Clearance details
- K-number
- K772243
- Device name
- TOXO TEST
- Applicant
- Gull Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-12-08
- Decision date
- 1977-12-22
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- GLZ
- Device class
- 2
- Regulation number
- 866.3780
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Gull Laboratories
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 |
|---|---|---|
| TOXOPLASMA IGM IFA TEST SYSTEM (K924882) | Zeus Scientific, Inc. | 1993-03-23 |
| TOXO IGM TEST (K880007) | Gull Laboratories, Inc. | 1988-03-17 |
| FIAX TOXO-M ANTIBODIES TEST KIT (K850591) | Intl. Diagnostic Technology | 1985-04-30 |
| ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII (K844287) | Apple Diagnostic Products | 1985-01-07 |
| ANTI-TOXOPLASMA GONDII KIT (K842664) | Amico Lab, Inc. | 1984-08-28 |
| IMMUNOENZYME TEST SYS-DETECT-IGM ANTI (K832900) | Bionetic Laboratory Products | 1983-11-14 |
| POLYCHACO INDIRECT IMMUNOFLUORESCENCE (K830869) | Parasitic Disease Consultants | 1983-08-11 |
| TOXOPLASMOSIS TEST KIT (K811562) | Immuno-Diagnostic Products, Inc. | 1981-07-16 |
| TOXOPLASMA GONDII SEROLOGICAL REAGENTS (K803134) | Microbiological Research Corp. | 1981-01-29 |
| TOXO BIO-BEAD TITRATION KIT (K801720) | Litton Bionetics | 1980-09-16 |
| TORCH BIO-BEAD SCREEN KIT (K791618) | Litton Bionetics | 1979-11-13 |
| TOXO BIO-BEAD SCREEN KIT (K791611) | Litton Bionetics | 1979-11-13 |
Recalls involving this device
No recalls on record reference this clearance.