FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHEMISTRY CONTROL, ABNORMAL
K Number: K770312
·
Decision Apr 5, 1977
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
30
Review Days
48
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Basic Information
- Device Name
- CHEMISTRY CONTROL, ABNORMAL
- K Number
- K770312
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Icn Pharmaceuticals, Inc.
- Date Received
- February 16, 1977
- Decision Date
- April 5, 1977
- Product Code
- JJY
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | FDA class 1 | Clinical Chemistry |
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Other Clearances by Icn Pharmaceuticals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K022817 | COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II | Nov 22, 2002 | Substantially Equivalent |
| K951329 | IMMUCHEM GAL-MW EA | Nov 9, 1995 | Substantially Equivalent |
| K914530 | ICAN GT DRAINAGE BAG | Dec 18, 1991 | Substantially Equivalent |
| K914082 | SUAN FLAT DISSECTOR SPONGES | Nov 27, 1991 | Substantially Equivalent |
| K914083 | ICAN K DISSECTOR SPONGES | Oct 9, 1991 | Substantially Equivalent |
| K914086 | ICAN CYLINDRICAL SPONGES | Oct 9, 1991 | Substantially Equivalent |
| K914081 | ICAN COTTON RAYON BALLS | Oct 9, 1991 | Substantially Equivalent |
| K913446 | ICAN NEEDLE COUNTERS | Sep 13, 1991 | Substantially Equivalent |
| K904398 | WATER COLUMN RELIEF VALVE | Jul 9, 1991 | Substantially Equivalent |
| K770458 | BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR. | May 10, 1977 | Substantially Equivalent |