FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENCORE PROLACTIN REAGENT
K Number: K860221
·
Decision Mar 5, 1986
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
79
Applicant Total
63
Review Days
42
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Basic Information
- Device Name
- ENCORE PROLACTIN REAGENT
- K Number
- K860221
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1625
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Hybritech, Inc.
- Date Received
- January 22, 1986
- Decision Date
- March 5, 1986
- Product Code
- CFT
- 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 |
|---|---|---|---|
| CFT | Radioimmunoassay, Prolactin (Lactogen) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
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| 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 |