FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET
K Number: K884197
·
Decision Dec 14, 1988
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
244
Applicant Total
38
Review Days
69
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
- DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET
- K Number
- K884197
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Casco Standards
- Date Received
- October 6, 1988
- Decision Date
- December 14, 1988
- Product Code
- JIT
- 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 |
|---|---|---|---|
| JIT | Calibrator, Secondary | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JIT), ordered by most recent decision date.
VITROS Immunodiagnostic Products Insulin Calibrators
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CalSet IGF-1
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Abbott ARCHITECT Free T3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Lumipulse G Progesterone-N Calibrators
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Lumipulse G FSH-N Calibrators
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Lumipulse G LH Calibrators
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Casco Standards
| K Number | Device Name | ||
|---|---|---|---|
| K981436 | DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109 | Apr 24, 1998 | Substantially Equivalent |
| K972904 | DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL | Feb 20, 1998 | Substantially Equivalent |
| K962629 | DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR | Sep 13, 1996 | Substantially Equivalent |
| K962630 | DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL | Jul 22, 1996 | Substantially Equivalent |
| K961750 | DOCUMENT CARDIAC ASSAYED CONTROL | Jul 22, 1996 | Substantially Equivalent |
| K960244 | DOCUMENT TDM ULTRA ASSAYED CONTROL | Mar 22, 1996 | Substantially Equivalent |
| K955155 | DOCUMENT TDM ULTRA UNASSAYED CONTROL | Dec 20, 1995 | Substantially Equivalent |
| K950469 | DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET | Apr 11, 1995 | Substantially Equivalent |
| K945718 | DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET | Jan 17, 1995 | Substantially Equivalent |
| K945315 | DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL | Dec 9, 1994 | Substantially Equivalent |