FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PF TEST
K Number: K884513
·
Decision Feb 3, 1989
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
13
Applicant Total
36
Review Days
99
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Basic Information
- Device Name
- PF TEST
- K Number
- K884513
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3255
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Medi-Tech, Inc.
- Date Received
- October 27, 1988
- Decision Date
- February 3, 1989
- Product Code
- GMZ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| GMZ | Antigens, All Types, Escherichia Coli | FDA class 1 | Microbiology |
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Other Clearances by Medi-Tech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| K943290 | BILIRUBIN PLUS/PEDIATRIC CONTROLS | Sep 14, 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 |