FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)
K Number: K862255
·
Decision Jul 29, 1986
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
110
Applicant Total
41
Review Days
46
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
- LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)
- K Number
- K862255
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1440
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Sterling Diagnostics, Inc.
- Date Received
- June 13, 1986
- Decision Date
- July 29, 1986
- Product Code
- CFJ
- 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 |
|---|---|---|---|
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CFJ), ordered by most recent decision date.
ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LIQUID LDH-L REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LACTATE DEHYDROGENASE (LD)
FDA 510(k)
FDA Class 2
·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 |
| K914040 | PHOSPHOLIPID REAGENT SET | Oct 30, 1991 | 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 |