FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CK-MB/LD-1 CONTROL SYSTEM
K Number: K894207
·
Decision Aug 28, 1989
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
96
Applicant Total
340
Review Days
70
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
- CK-MB/LD-1 CONTROL SYSTEM
- K Number
- K894207
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Boehringer Mannheim Corp.
- Date Received
- June 19, 1989
- Decision Date
- August 28, 1989
- Product Code
- JJT
- 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 |
|---|---|---|---|
| JJT | Enzyme Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJT), ordered by most recent decision date.
SPOTCHECK BLOOD SPOT CONTROL, ASSAYED
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
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 |