FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QTEST(R) STREP
K Number: K935667
·
Decision Apr 21, 1994
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
43
Applicant Total
10
Review Days
146
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Basic Information
- Device Name
- QTEST(R) STREP
- K Number
- K935667
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Becton Dickinson Advanced Diagnostics
- Date Received
- November 26, 1993
- Decision Date
- April 21, 1994
- Product Code
- GTY
- 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 |
|---|---|---|---|
| GTY | Antigens, All Groups, Streptococcus Spp. | FDA class 1 | Microbiology |
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Other Clearances by Becton Dickinson Advanced Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K931294 | IQ TUPTAKE ASSAY | Jul 22, 1993 | Substantially Equivalent |
| K931295 | IQ TT4 ASSAY | Jul 20, 1993 | Substantially Equivalent |
| K926356 | PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG | Mar 18, 1993 | Substantially Equivalent |
| K925132 | BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE | Dec 28, 1992 | Substantially Equivalent |
| K923673 | PRECISE STREP A | Sep 28, 1992 | Substantially Equivalent |
| K923060 | IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY | Sep 15, 1992 | Substantially Equivalent |
| K914958 | RIATRAC PLUS | Mar 18, 1992 | Substantially Equivalent |
| K915197 | PRECISE TM HCG | Dec 17, 1991 | Substantially Equivalent |
| K915200 | PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA | Dec 16, 1991 | Substantially Equivalent |