FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT
K Number: K851703
·
Decision Aug 23, 1985
Classifications
1
FEI Numbers
145
Registration Numbers
145
Same Product Code
399
Applicant Total
158
Review Days
121
Basic Information
- Device Name
- GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT
- K Number
- K851703
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- MILES LABORATORIES, INC.
- Date Received
- April 24, 1985
- Decision Date
- August 23, 1985
- Product Code
- CGA
- 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| 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 |
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| K865053 | SERA-TEK MICROSOMAL ANTIBODY TEST | Feb 18, 1987 | Substantially Equivalent |