FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FEKAL CHECK PARASITOLOGY CONTROL SLIDE
K Number: K862914
·
Decision Sep 16, 1986
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
11
Applicant Total
6
Review Days
46
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Basic Information
- Device Name
- FEKAL CHECK PARASITOLOGY CONTROL SLIDE
- K Number
- K862914
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2480
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Trend Scientific, Inc.
- Date Received
- August 1, 1986
- Decision Date
- September 16, 1986
- Product Code
- JTR
- 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 |
|---|---|---|---|
| JTR | Kit, Quality Control For Culture Media | FDA class 1 | Microbiology |
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Other Clearances by Trend Scientific, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954996 | TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM | Aug 8, 1996 | Substantially Equivalent |
| K955755 | TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS | Jul 11, 1996 | Substantially Equivalent |
| K952467 | TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT) | Nov 20, 1995 | Substantially Equivalent |
| K953284 | TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM | Oct 6, 1995 | Substantially Equivalent |
| K830769 | FEKAL CON-TRATE SYSTEM | Apr 5, 1983 | Substantially Equivalent |