FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ICON READER
K Number: K862956
·
Decision Aug 19, 1986
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
17
Applicant Total
63
Review Days
14
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Basic Information
- Device Name
- ICON READER
- K Number
- K862956
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2400
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Hybritech, Inc.
- Date Received
- August 5, 1986
- Decision Date
- August 19, 1986
- Product Code
- JQT
- 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 |
|---|---|---|---|
| JQT | Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JQT), ordered by most recent decision date.
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TARGET READER
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APOLLO DENSITOMETER
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·Clinical Chemistry
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 |