FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SERA-TEK MICROSOMAL ANTIBODY TEST
K Number: K865053
·
Decision Feb 18, 1987
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
90
Applicant Total
158
Review Days
56
Basic Information
- Device Name
- SERA-TEK MICROSOMAL ANTIBODY TEST
- K Number
- K865053
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5870
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- MILES LABORATORIES, INC.
- Date Received
- December 24, 1986
- Decision Date
- February 18, 1987
- Product Code
- JZO
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| JZO | System, Test, Thyroid Autoantibody | FDA class 2 | Immunology |
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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 |
| K870752 | SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS | Apr 14, 1987 | Substantially Equivalent |
| K864530 | SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. | Feb 18, 1987 | Substantially Equivalent |