FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LDH-INT TEST
K Number: K771343
·
Decision Aug 10, 1977
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
12
Applicant Total
22
Review Days
21
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Basic Information
- Device Name
- LDH-INT TEST
- K Number
- K771343
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1440
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Hycel, Inc.
- Date Received
- July 20, 1977
- Decision Date
- August 10, 1977
- Product Code
- CFH
- 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 |
|---|---|---|---|
| CFH | Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CFH), ordered by most recent decision date.
SPOTCHEM II LDH TEST
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CARESIDE LDH
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CLINISTAT LDH REAGENT TEST
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IQ LDH
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LACTATE DEHYDROGENASE (LDH-L)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LACTATE DEHYDROGENASE (LDH) REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Hycel, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K802422 | HYCEL TRIGYCERIDE II TEST | Oct 6, 1980 | Unknown |
| K790335 | HYCEL M | Feb 27, 1979 | Substantially Equivalent |
| K782116 | KETOSTEROID TEST, HYCEL-17 | Jan 26, 1979 | Substantially Equivalent |
| K782176 | HYCEL LDH-INT TEST | Jan 26, 1979 | Substantially Equivalent |
| K782102 | HYCEL COUNTER 211 | Jan 3, 1979 | Substantially Equivalent |
| K782100 | HYCEL COUNTER 333 | Jan 3, 1979 | Substantially Equivalent |
| K782101 | HYCEL COUNTER 222 | Jan 3, 1979 | Substantially Equivalent |
| K781004 | HMA URIC ACID TEST | Jul 27, 1978 | Substantially Equivalent |
| K780946 | ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER | Jul 27, 1978 | Substantially Equivalent |
| K780464 | LELECTIVE KINETIC SYSTEM-60 | May 3, 1978 | Substantially Equivalent |