FDA 510(k)
Substantially Equivalent
🇺🇸 United States
TUBES, HYDROLYSIS, CALIBRATED
K Number: K770605
·
Decision Jun 15, 1977
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
41
Review Days
76
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Basic Information
- Device Name
- TUBES, HYDROLYSIS, CALIBRATED
- K Number
- K770605
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Organon, Inc.
- Date Received
- March 31, 1977
- Decision Date
- June 15, 1977
- Advisory Committee
- Unknown
- Review Advisory Committee
- CH
- Third Party
- N
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|---|---|---|---|
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| K841525 | OREIA II B-HCG PREGNANCY TEST KIT | Jun 5, 1984 | Substantially Equivalent |
| K841602 | ACCURATE BETA 30 PREGNANCY TEST KIT | May 22, 1984 | Substantially Equivalent |
| K840650 | B-NEOCEPT 30 | Apr 4, 1984 | Substantially Equivalent |
| K832801 | OREIA II B-HCG, ENZYME INNUNOASSAY | Dec 8, 1983 | Substantially Equivalent |
| K831339 | NEO-PREGNOSTICON DUOCLON TUBE TEST | Jun 8, 1983 | Substantially Equivalent |
| K831109 | DUOCLON SLIDE TEST | Jun 2, 1983 | Substantially Equivalent |
| K823682 | BETA FFIRM TEST | Jan 7, 1983 | Substantially Equivalent |