Porphobilinogen (PBG)
FDA 510(k) K961984 · Trace America, Inc.
510(k) numberK961984
Submission
- Device name
- Porphobilinogen (PBG)
- Applicant
- Trace America, Inc.
Miami, FL, US - Received
- May 21, 1996
- Decision date
- December 10, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JNF – Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1590
- Specialty
- Clinical Chemistry
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Questions and answers
When was Porphobilinogen (PBG) cleared by the FDA?
Porphobilinogen (PBG) (K961984) received a 510(k) decision of Substantially Equivalent on December 10, 1996, 203 days after the submission was received.
What is the product code of K961984?
The FDA product code is JNF – Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen, a Class I (low risk) device regulated under 21 CFR 862.1590.