FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RAPID COLORIMETRIC DIRECT STREP A TEST
K Number: K874761
·
Decision Feb 19, 1988
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
104
Applicant Total
10
Review Days
92
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Basic Information
- Device Name
- RAPID COLORIMETRIC DIRECT STREP A TEST
- K Number
- K874761
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- New Horizons Diagnostics Co.
- Date Received
- November 19, 1987
- Decision Date
- February 19, 1988
- Product Code
- GTZ
- 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 |
|---|---|---|---|
| GTZ | Antisera, All Groups, Streptococcus Spp. | FDA class 1 | Microbiology |
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Other Clearances by New Horizons Diagnostics Co.
| K Number | Device Name | ||
|---|---|---|---|
| K932622 | CHOLERA SMART(TM) | Jun 27, 1995 | Substantially Equivalent |
| K925190 | PYLORISCREEN | Mar 23, 1993 | Substantially Equivalent |
| K922432 | CHOLERASCREEN | Dec 7, 1992 | Substantially Equivalent |
| K871226 | SYPHILIS SEROLOGICAL REAGENTS | May 28, 1987 | Substantially Equivalent |
| K871105 | THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE | May 13, 1987 | Substantially Equivalent |
| K862195 | RAPID BACTERIURIA SCREEN (RBS) | Jun 30, 1986 | Substantially Equivalent |
| K851132 | LATEX AGGLUTINATION TEST | Jul 5, 1985 | Substantially Equivalent |
| K821362 | IMPROVED GONO GEN | Aug 4, 1982 | Substantially Equivalent |
| K820007 | NEISSERIA GONORRHOEAE TEST | Jan 29, 1982 | Substantially Equivalent |