FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ADJUSTABLE DISPENSOR
K Number: K780912
·
Decision Jun 28, 1978
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
139
Applicant Total
9
Review Days
23
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Basic Information
- Device Name
- ADJUSTABLE DISPENSOR
- K Number
- K780912
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2750
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Oxford Laboratories, Inc.
- Date Received
- June 5, 1978
- Decision Date
- June 28, 1978
- Product Code
- JQW
- 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 |
|---|---|---|---|
| JQW | Station, Pipetting And Diluting, For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Oxford Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K760078 | REAGENT, RIA TRIIODOTHYRONINE T3 (#200) | Jul 20, 1976 | Substantially Equivalent |
| K760147 | SERUM, IGM ANTI-HUMAN ACID | Jul 20, 1976 | Substantially Equivalent |
| K760143 | SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN | Jul 20, 1976 | Substantially Equivalent |
| K760079 | REAGENT, THYROXINE T4 (#210) | Jul 20, 1976 | Substantially Equivalent |
| K760144 | SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID | Jul 20, 1976 | Substantially Equivalent |
| K760146 | SERUM, IGA GOAT ANTI-HUMAN ACID | Jul 20, 1976 | Substantially Equivalent |
| K760148 | SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN | Jul 20, 1976 | Substantially Equivalent |
| K760145 | SERUM, IGG GOAT ANTI-HUMAN ACID | Jul 19, 1976 | Substantially Equivalent |