FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ICON STREP B IMMUNOENZYMETRIC ASSAY
K Number: K911417
·
Decision Jul 24, 1991
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
104
Applicant Total
63
Review Days
114
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Basic Information
- Device Name
- ICON STREP B IMMUNOENZYMETRIC ASSAY
- K Number
- K911417
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Hybritech, Inc.
- Date Received
- April 1, 1991
- Decision Date
- July 24, 1991
- 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 Hybritech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972666 | TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY | Sep 11, 1997 | Substantially Equivalent |
| K961573 | TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY | Aug 19, 1996 | Substantially Equivalent |
| K930810 | TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY | Jan 11, 1994 | Substantially Equivalent |
| K922754 | TANDEM-E IGE II CALIBRATION VERIFICATION SET | Feb 17, 1993 | Substantially Equivalent |
| K921745 | HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO | Jul 30, 1992 | Substantially Equivalent |
| K921252 | TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL | Jul 17, 1992 | Substantially Equivalent |
| K920556 | TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET | Jul 17, 1992 | Substantially Equivalent |
| K921763 | TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY | Jun 9, 1992 | Substantially Equivalent |
| K912439 | TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET | Aug 28, 1991 | Substantially Equivalent |
| K902991 | ICON STREP B IMMUNOENZYMETRIC ASSAY | Oct 3, 1990 | Substantially Equivalent |