HI-M-TEST FOR METHADONE TEST #2
FDA 510(k) clearance K801509 · decided 1980-07-14
Clearance details
- K-number
- K801509
- Device name
- HI-M-TEST FOR METHADONE TEST #2
- Applicant
- Technam, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-06-30
- Decision date
- 1980-07-14
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- DIW
- Device class
- 2
- Regulation number
- 862.3620
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- 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 |
|---|---|---|
| URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE (K950182) | E.I. Dupont DE Nemours & Co., Inc. | 1995-03-21 |
| ROCHE ABUSCREEN ONTRAK FOR METHADONE (K930845) | Roche Diagnostic Systems, Inc. | 1993-04-20 |
| KIT, METHADONE (TOXI-PAK IMMUNO HI) (K760075) | J.T. Baker Chemical Co. | 1976-07-20 |
Recalls involving this device
No recalls on record reference this clearance.