FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS
K Number: K870752
·
Decision Apr 14, 1987
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
110
Applicant Total
158
Review Days
48
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Basic Information
- Device Name
- SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS
- K Number
- K870752
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1440
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Miles Laboratories, Inc.
- Date Received
- February 25, 1987
- Decision Date
- April 14, 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
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
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LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30
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LIQUID LDH-L REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LACTATE DEHYDROGENASE (LD)
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Other Clearances by Miles Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880605 | LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER | May 26, 1988 | Substantially Equivalent |
| K874909 | MICRO-BUMINTEST REAGENT TABLETS | Apr 28, 1988 | Substantially Equivalent |
| K875079 | MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE | Apr 5, 1988 | Substantially Equivalent |
| K871835 | GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT | Dec 22, 1987 | Substantially Equivalent |
| K872120 | SERALYZER III BLOOD CHEMISTRY ANALYZER | Oct 28, 1987 | Substantially Equivalent |
| K873304 | CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) | Sep 11, 1987 | Substantially Equivalent |
| K872634 | CUTTER PUREFLO PLUS IV FILTER | Aug 4, 1987 | Substantially Equivalent |
| K870214 | MODIFIED SALTEX REAGENT STRIPS | Jun 29, 1987 | Substantially Equivalent |
| K865053 | SERA-TEK MICROSOMAL ANTIBODY TEST | Feb 18, 1987 | Substantially Equivalent |
| K864530 | SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. | Feb 18, 1987 | Substantially Equivalent |