FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACE HDL-C REAGENT
K Number: K971526
·
Decision May 21, 1997
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
79
Applicant Total
24
Review Days
23
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
- ACE HDL-C REAGENT
- K Number
- K971526
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Schiapparelli Biosystems, Inc.
- Date Received
- April 28, 1997
- Decision Date
- May 21, 1997
- Product Code
- LBS
- 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 |
|---|---|---|---|
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LBS), ordered by most recent decision date.
HDL-Cholesterol Gen.4
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Direct HDL Cholesterol (HDL)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VITROS CHEMISTRY PRODUCTS DHDL SLIDES
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NMR LIPOPROFILE (R) TEST AND NMR PROFILER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Schiapparelli Biosystems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K991733 | ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS | Jul 13, 1999 | Substantially Equivalent |
| K981377 | ACE T4 REAGENT T4 CALIBRATORS | Jun 10, 1998 | Substantially Equivalent |
| K981375 | ACE T UPTAKE REAGENT TU CALIBRATORS | Jun 10, 1998 | Substantially Equivalent |
| K973581 | ACE VALPROIC ACID REAGENT, AED CALIBRATORS | Nov 12, 1997 | Substantially Equivalent |
| K973583 | ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS | Nov 12, 1997 | Substantially Equivalent |
| K973582 | ACE PRIMIDONE REAGENT, AED CALIBRATORS | Nov 12, 1997 | Substantially Equivalent |
| K973536 | ACE PHENOBARBITAL REAGENT/AED CALIBRATORS | Nov 6, 1997 | Substantially Equivalent |
| K973414 | ACE PHENYTOIN REAGENT, AED CALIBRATORS | Nov 4, 1997 | Substantially Equivalent |
| K973535 | ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS | Oct 20, 1997 | Substantially Equivalent |
| K954179 | HDL PRECIPITATING REAGENT | Dec 11, 1995 | Substantially Equivalent |