FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ONE-STEP HCG
K Number: K882896
·
Decision Oct 31, 1988
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
71
Applicant Total
12
Review Days
112
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Basic Information
- Device Name
- ONE-STEP HCG
- K Number
- K882896
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Wampole Laboratories
- Date Received
- July 11, 1988
- Decision Date
- October 31, 1988
- Product Code
- DHA
- 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 |
|---|---|---|---|
| DHA | System, Test, Human Chorionic Gonadotropin | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| K911444 | RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM | Aug 30, 1991 | Substantially Equivalent |
| K883004 | MONO-PLUS(TM) | Aug 4, 1988 | Substantially Equivalent |
| K875101 | VIROGEN CMV ANTIBODY TEST | Mar 1, 1988 | Substantially Equivalent |
| K875161 | MAT (TM) MICROALBUMIN TEST | Feb 17, 1988 | Substantially Equivalent |
| K791309 | UCG-LYPHOTEST | Jul 30, 1979 | Substantially Equivalent |
| K790986 | RF CONTROLS | Jun 28, 1979 | Substantially Equivalent |
| K781794 | BETA-TEC | Dec 29, 1978 | Substantially Equivalent |
| K760336 | BIOCEPT-G | Nov 12, 1976 | Substantially Equivalent |