PORPHOBILINOGEN (PBG)
FDA 510(k) clearance K961984 · decided 1996-12-10
Clearance details
- K-number
- K961984
- Device name
- PORPHOBILINOGEN (PBG)
- Applicant
- Trace America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-05-21
- Decision date
- 1996-12-10
- Days to decision
- 203 days
- Clearance type
- Traditional
- Product code
- JNF
- Device class
- 1
- Regulation number
- 862.1590
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Trace America
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.