FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PHADEBAS HUMYLASE CONTROL(H)
K Number: K823421
·
Decision Apr 5, 1983
Classifications
1
FEI Numbers
280
Registration Numbers
280
Same Product Code
492
Applicant Total
129
Review Days
138
Basic Information
- Device Name
- PHADEBAS HUMYLASE CONTROL(H)
- K Number
- K823421
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- PHARMACIA, INC.
- Date Received
- November 18, 1982
- Decision Date
- April 5, 1983
- Product Code
- JJX
- 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 |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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|---|---|---|---|
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| K962274 | UNICAP 100 | Sep 12, 1996 | Substantially Equivalent |
| K941993 | PHARMACIA CAP SYSTEM PHADIATOP FEIA | Jan 30, 1996 | Substantially Equivalent |
| K954337 | GENOTROPIN MIXER | Nov 13, 1995 | Substantially Equivalent |
| K951025 | PISTON SYRINGE | Oct 19, 1995 | Substantially Equivalent |
| K952025 | ROBOCAP | Jul 26, 1995 | Substantially Equivalent |