FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CK/LD ISOENZYMES CONTROLS(HUMAN)
K Number: K851520
·
Decision Jun 25, 1985
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
96
Applicant Total
20
Review Days
71
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/LD ISOENZYMES CONTROLS(HUMAN)
- K Number
- K851520
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Seragen Diagnostics, Inc.
- Date Received
- April 15, 1985
- Decision Date
- June 25, 1985
- 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 Seragen Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K872148 | VIVID CHLAMYDIA(TM) | Aug 19, 1987 | Substantially Equivalent |
| K851663 | QUICK-COUNT HEMATOLOGY CONTROLS | Jul 23, 1985 | Substantially Equivalent |
| K852260 | QUICK-CHEM CALIBRATION SET | Jul 22, 1985 | Substantially Equivalent |
| K851521 | LD-1(IMMUNO) SEPARATION SET | May 10, 1985 | Substantially Equivalent |
| K850209 | QUICK-LYTE | Feb 27, 1985 | Substantially Equivalent |
| K844743 | SERATEST ENA(RNP/SM) DETERMINATION | Feb 4, 1985 | Substantially Equivalent |
| K842563 | SERATEST DNA DETERMINATION | Oct 25, 1984 | Substantially Equivalent |
| K841504 | QUICK-COUNT PLUS 2 | Jun 11, 1984 | Substantially Equivalent |
| K840793 | CK/MB IMMUNO-ISOENZYME CONTROL SERUM | Apr 13, 1984 | Substantially Equivalent |
| K840863 | SERATEST RF LATEX DETERMINATION | Apr 4, 1984 | Substantially Equivalent |