FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TINA-QUANT PREALBUMIN
K Number: K972638
·
Decision Jan 9, 1998
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
10
Applicant Total
340
Review Days
178
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TINA-QUANT PREALBUMIN
- K Number
- K972638
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.5060
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boehringer Mannheim Corp.
- Date Received
- July 15, 1997
- Decision Date
- January 9, 1998
- Product Code
- JZJ
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JZJ | Prealbumin, Antigen, Antiserum, Control | FDA class 1 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JZJ), ordered by most recent decision date.
RANDOX PREALBUMIN
FDA 510(k)
FDA Class 1
·Immunology
HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT
FDA 510(k)
FDA Class 1
·Immunology
PREALBUMIN IMMUNOLOGICAL NL TEST KIT
FDA 510(k)
FDA Class 1
·Immunology
SPQ(TM) TEST SYSTEM FOR PREALBUMIN
FDA 510(k)
FDA Class 1
·Immunology
SPQ(TM) TEST SYSTEM FOR MICROALBUMIN
FDA 510(k)
FDA Class 1
·Immunology
QM300 PREALBUMIN ANTIBODY PACK
FDA 510(k)
FDA Class 1
·Immunology
Other Clearances by Boehringer Mannheim Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K984326 | ELECYS IGE ASSAY | Feb 8, 1999 | Substantially Equivalent |
| K983047 | ACCU-CHEK HQ SYSTEM | Feb 5, 1999 | Substantially Equivalent |
| K984419 | ELECSYS IGE CALCHECK | Feb 2, 1999 | Substantially Equivalent |
| K984425 | MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR | Jan 20, 1999 | Substantially Equivalent |
| K984372 | ELECSYS CALCHECK TROPONIN T | Dec 14, 1998 | Substantially Equivalent |
| K984105 | ELECSYS TROPONIN T STAT TEST | Dec 8, 1998 | Substantially Equivalent |
| K983503 | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 | Dec 1, 1998 | Substantially Equivalent |
| K983469 | PRECISET SERUM PROTEINS CALIBRATOR | Nov 25, 1998 | Substantially Equivalent |
| K983185 | BOEHRINGER MANNHEIM TINA-QUANT IGE TEST | Nov 12, 1998 | Substantially Equivalent |
| K982949 | ELECSYS PSA, MODEL 2010 | Oct 27, 1998 | Substantially Equivalent |