FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HDL PRECIPITATING REAGENT
K Number: K893966
·
Decision Jul 25, 1989
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
65
Applicant Total
14
Review Days
53
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
- HDL PRECIPITATING REAGENT
- K Number
- K893966
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Diagnostic Systems
- Date Received
- June 2, 1989
- Decision Date
- July 25, 1989
- Product Code
- LBR
- 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 |
|---|---|---|---|
| LBR | Ldl & Vldl Precipitation, Hdl | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LBR), ordered by most recent decision date.
LDLC3 LDL-Cholesterol Gen.3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Diagnostic Systems
| K Number | Device Name | ||
|---|---|---|---|
| K905146 | OLYMPUS URINE PH | Feb 4, 1991 | Substantially Equivalent |
| K893691 | EMDS CREATINE KINASE ITEM NIMBER 65411 | Aug 31, 1989 | Substantially Equivalent |
| K893692 | EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405 | Aug 21, 1989 | Substantially Equivalent |
| K884993 | VISUAL BLOOD GLUCOSE TEST SYSTEM | Dec 29, 1988 | Substantially Equivalent |
| K881116 | EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 | Jun 20, 1988 | Substantially Equivalent |
| K880787 | EASY-TEST LACTIC ACID (LA) | Mar 15, 1988 | Substantially Equivalent |
| K862403 | EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 | Jul 11, 1986 | Substantially Equivalent |
| K854784 | ABSORBANCE (ABS) TEST PAK | Dec 19, 1985 | Substantially Equivalent |
| K853699 | EASY ANALYZER & EASY-TEST REAGENT | Sep 25, 1985 | Substantially Equivalent |
| K853532 | ALCOHOL CALIBRATORS | Sep 16, 1985 | Substantially Equivalent |