FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNI-FAST LACTATE DEHYDROGENASE (LDH-L)
K Number: K872030
·
Decision Jul 7, 1987
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
110
Applicant Total
82
Review Days
42
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Basic Information
- Device Name
- UNI-FAST LACTATE DEHYDROGENASE (LDH-L)
- K Number
- K872030
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1440
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Sclavo, Inc.
- Date Received
- May 26, 1987
- Decision Date
- July 7, 1987
- 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
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ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT
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LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30
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LACTATE DEHYDROGENASE (LD)
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Other Clearances by Sclavo, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K914789 | ELISA CMV IGM | Mar 4, 1992 | Substantially Equivalent |
| K914852 | ELISA TOXO IGM | Jan 23, 1992 | Substantially Equivalent |
| K914420 | ELISA RUBELLA IGM | Dec 27, 1991 | Substantially Equivalent |
| K895943 | NORMAL AND ABNORMAL CONTROL SERA | Dec 27, 1989 | Substantially Equivalent |
| K895822 | TOTAL BILIRUBIN L.F. | Nov 14, 1989 | Substantially Equivalent |
| K895847 | CREATININE 340 (ENZYMATIC) | Oct 30, 1989 | Substantially Equivalent |
| K880049 | CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE | Jan 27, 1989 | Substantially Equivalent |
| K880199 | CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE | Jan 27, 1989 | Substantially Equivalent |
| K873496 | ATYPICAL CHOLINESTERASE | Jan 27, 1989 | Substantially Equivalent |
| K884035 | SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER | Dec 29, 1988 | Substantially Equivalent |