PRP-1 REVERSED PHASE RESIN
FDA 510(k) clearance K832197 · decided 1983-08-12
Clearance details
- K-number
- K832197
- Device name
- PRP-1 REVERSED PHASE RESIN
- Applicant
- Hamilton Co.
- Decision
- Substantially Equivalent
- Date received
- 1983-07-07
- Decision date
- 1983-08-12
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- DMZ
- Device class
- 1
- Regulation number
- 862.2260
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Hamilton Co.
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.
Recalls involving this device
No recalls on record reference this clearance.