FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SERALYZER III BLOOD CHEMISTRY ANALYZER
K Number: K872120
·
Decision Oct 28, 1987
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
56
Applicant Total
158
Review Days
149
Basic Information
- Device Name
- SERALYZER III BLOOD CHEMISTRY ANALYZER
- K Number
- K872120
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2170
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- MILES LABORATORIES, INC.
- Date Received
- June 1, 1987
- Decision Date
- October 28, 1987
- Product Code
- JJF
- 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 |
|---|---|---|---|
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJF), ordered by most recent decision date.
ETI-MAX 3000
FDA 510(k)
FDA Class 1
·Clinical Chemistry
POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIGHTCYCLER INSTRUMENT VERSION 1.2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ROCHE COBAS TAQMAN ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CARESIDE ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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 |
| 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 |
| K870752 | SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS | Apr 14, 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 |