FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TANDEM R-TOTAL B-GCG KIT
K Number: K833194
·
Decision Jan 18, 1984
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
374
Applicant Total
63
Review Days
121
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Basic Information
- Device Name
- TANDEM R-TOTAL B-GCG KIT
- K Number
- K833194
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Hybritech, Inc.
- Date Received
- September 19, 1983
- Decision Date
- January 18, 1984
- Product Code
- JHI
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | FDA class 2 | Clinical Chemistry |
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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 |
| K911417 | ICON STREP B IMMUNOENZYMETRIC ASSAY | Jul 24, 1991 | Substantially Equivalent |