FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET
K Number: K861855
·
Decision Jun 16, 1986
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
41
Review Days
33
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Basic Information
- Device Name
- HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET
- K Number
- K861855
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1380
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Sterling Diagnostics, Inc.
- Date Received
- May 14, 1986
- Decision Date
- June 16, 1986
- Product Code
- JKF
- 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 |
|---|---|---|---|
| JKF | Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JKF), ordered by most recent decision date.
View allOther 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 |
| 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 |
| K861713 | SERUM POTASSIUM REAGENT SET | May 23, 1986 | Substantially Equivalent |