FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PORPHOBILINOGEN (PBG)
K Number: K961984
·
Decision Dec 10, 1996
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
22
Review Days
203
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Basic Information
- Device Name
- PORPHOBILINOGEN (PBG)
- K Number
- K961984
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1590
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Trace America, Inc.
- Date Received
- May 21, 1996
- Decision Date
- December 10, 1996
- Product Code
- JNF
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JNF | Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen | FDA class 1 | Clinical Chemistry |
Other Clearances by Trace America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K003583 | LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 | Jan 17, 2001 | Substantially Equivalent |
| K980026 | GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | Mar 10, 1998 | Substantially Equivalent |
| K980028 | ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | Feb 2, 1998 | Substantially Equivalent |
| K980030 | AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | Jan 30, 1998 | Substantially Equivalent |
| K973869 | TRACE REAGENT LINE FOR THE COBAS MIRA | Jan 7, 1998 | Substantially Equivalent |
| K974620 | AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) | Jan 2, 1998 | Substantially Equivalent |
| K972297 | AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | Jul 17, 1997 | Substantially Equivalent |
| K971477 | UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) | May 27, 1997 | Substantially Equivalent |
| K971485 | URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | May 27, 1997 | Substantially Equivalent |
| K962723 | TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN | Mar 13, 1997 | Substantially Equivalent |