FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PHOSPHOLIPID REAGENT SET
K Number: K914040
·
Decision Oct 30, 1991
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
2
Applicant Total
41
Review Days
50
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
- PHOSPHOLIPID REAGENT SET
- K Number
- K914040
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1575
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sterling Diagnostics, Inc.
- Date Received
- September 10, 1991
- Decision Date
- October 30, 1991
- Product Code
- JNT
- 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 |
|---|---|---|---|
| JNT | Chromatographic, Phospholipids | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JNT), ordered by most recent decision date.
ZITHROMAX
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SUSCEPTIBILITY DISK, CINOXACIN 100 MCG.
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Sterling Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K921412 | MICROPROTEIN REAGENT SET | Jan 21, 1993 | Substantially Equivalent |
| K914609 | TRIGLYCERIDES REAGENT SET | Nov 7, 1991 | Substantially Equivalent |
| K914039 | SODIUM REAGENT SET | Oct 31, 1991 | Substantially Equivalent |
| K862255 | LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE) | Jul 29, 1986 | Substantially Equivalent |
| K861962 | VANILMANDELIC ACID (VMA) REAGENT SET | Jul 7, 1986 | Substantially Equivalent |
| K862210 | UREA NITROGEN (GLDH) REAGENT SET (UV) | Jul 1, 1986 | Substantially Equivalent |
| K862256 | ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET | Jul 1, 1986 | Substantially Equivalent |
| K862209 | ALT (SGPT) REAGENT SET (UV RATE) | Jun 25, 1986 | Substantially Equivalent |
| K861855 | HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET | Jun 16, 1986 | Substantially Equivalent |
| K861713 | SERUM POTASSIUM REAGENT SET | May 23, 1986 | Substantially Equivalent |