OSMOLARITY STANDARDS
FDA 510(k) clearance K844589 · decided 1985-03-01
Clearance details
- K-number
- K844589
- Device name
- OSMOLARITY STANDARDS
- Applicant
- Rna Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1984-11-26
- Decision date
- 1985-03-01
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- JMZ
- Device class
- 1
- Regulation number
- 862.1540
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Woburn, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Rna Medical Corp.
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 |
|---|---|---|
| URI-VAL (K843680) | Cenogenics Corp. | 1985-03-29 |
Recalls involving this device
No recalls on record reference this clearance.