HI-M-TEST MORPHINE
FDA 510(k) clearance K791551 · decided 1979-10-17
Clearance details
- K-number
- K791551
- Device name
- HI-M-TEST MORPHINE
- Applicant
- Technam, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-08-14
- Decision date
- 1979-10-17
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- DLR
- Device class
- 2
- Regulation number
- 862.3640
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Technam
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 |
|---|---|---|
| KIT, MORPHINE (TOXI-PAK IMMUNO HI) (K760074) | J.T. Baker Chemical Co. | 1976-07-20 |
Recalls involving this device
No recalls on record reference this clearance.