FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PYRIDOXAL-5-PHOSPHATE STRIPES
K Number: K821805
·
Decision Jul 2, 1982
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
126
Applicant Total
340
Review Days
15
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
- PYRIDOXAL-5-PHOSPHATE STRIPES
- K Number
- K821805
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1030
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Boehringer Mannheim Corp.
- Date Received
- June 17, 1982
- Decision Date
- July 2, 1982
- Product Code
- CKA
- 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 |
|---|---|---|---|
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CKA), ordered by most recent decision date.
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACE ALT REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CARESIDE ALT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TRACE REAGENT LINE FOR THE COBAS MIRA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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 |