FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROSTATE SPECIFIC ANTIGEN CONTROL
K Number: K973099
·
Decision Sep 29, 1997
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
492
Applicant Total
13
Review Days
41
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Basic Information
- Device Name
- PROSTATE SPECIFIC ANTIGEN CONTROL
- K Number
- K973099
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Chemistry Systems, Inc.
- Date Received
- August 19, 1997
- Decision Date
- September 29, 1997
- Product Code
- JJX
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- IM
- 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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Other Clearances by Dade Chemistry Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973650 | TROPONIN (TROP) METHOD | Oct 20, 1997 | Substantially Equivalent |
| K973100 | PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR | Sep 29, 1997 | Substantially Equivalent |
| K973101 | PROSTATE SPECIFIC ANTIGEN METHOD | Sep 18, 1997 | Substantially Equivalent |
| K971141 | FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM | Apr 28, 1997 | Substantially Equivalent |
| K970387 | HUMAN CHORIONIC GONADOTROPIN METHOD | Mar 10, 1997 | Substantially Equivalent |
| K970393 | THYROID STIMULATING HORMONE METHOD | Mar 3, 1997 | Substantially Equivalent |
| K970336 | MMB CALIBRATOR | Mar 3, 1997 | Substantially Equivalent |
| K970396 | HUMAN CHORIONIC GONADOTROPIN CALIBRATOR | Feb 20, 1997 | Substantially Equivalent |
| K970389 | THYROID CALIBRATOR | Feb 18, 1997 | Substantially Equivalent |
| K970343 | MMB METHOD | Feb 14, 1997 | Substantially Equivalent |