FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BILIRUBIN PLUS/PEDIATRIC CONTROLS
K Number: K943290
·
Decision Sep 14, 1994
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
36
Review Days
68
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Basic Information
- Device Name
- BILIRUBIN PLUS/PEDIATRIC CONTROLS
- K Number
- K943290
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medi-Tech, Inc.
- Date Received
- July 8, 1994
- Decision Date
- September 14, 1994
- 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 Medi-Tech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954457 | MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER | May 15, 1996 | Substantially Equivalent |
| K952345 | MEDI-TECH PLATFORM GUIDE CATHETER | Aug 17, 1995 | Substantially Equivalent |
| K952056 | IMMUNOASSAY DRUGS OF ABUSE CONTROLS | Jun 1, 1995 | Substantially Equivalent |
| K945289 | DOA - IMMUNOASSAY CUT-OFF CALIBRATOR | Dec 13, 1994 | Substantially Equivalent |
| K942551 | THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED | Oct 6, 1994 | Substantially Equivalent |
| K922990 | HEMODIALYSIS BATH | Sep 12, 1994 | Substantially Equivalent |
| K942552 | THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED | Sep 9, 1994 | Substantially Equivalent |
| K904073 | COAGULATION REFERENCE PLASMA, ABNORMAL | Oct 22, 1990 | Substantially Equivalent |
| K895819 | MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL | Nov 2, 1989 | Substantially Equivalent for Some Indications |
| K873295 | PROSTATIC URETHRO. BALLOON DILATATION CATHETER | Jul 31, 1989 | Substantially Equivalent |