POLYCHACO FIA-ABS TEST FOR SYPHILIS
FDA 510(k) clearance K831296 · decided 1983-07-26
Clearance details
- K-number
- K831296
- Device name
- POLYCHACO FIA-ABS TEST FOR SYPHILIS
- Applicant
- Parasitic Disease Consultants
- Decision
- Substantially Equivalent
- Date received
- 1983-04-20
- Decision date
- 1983-07-26
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- JWL
- Device class
- 2
- Regulation number
- 866.3830
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| FTA-ABS BIOPAK (K802276) | Bioware Products | 1980-10-23 |
| FTA-ABS TEST (K801959) | Immuno-Diagnostic Products, Inc. | 1980-10-23 |
| LAB-TEK FTA-ABS KIT (K801928) | Miles Laboratories, Inc. | 1980-08-20 |
Recalls involving this device
No recalls on record reference this clearance.