FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
C&T PREGNANCY TEST KIT
K Number: K884489
·
Decision Mar 8, 1989
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
225
Applicant Total
9
Review Days
133
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Basic Information
- Device Name
- C&T PREGNANCY TEST KIT
- K Number
- K884489
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Healthcheck Corp.
- Date Received
- October 26, 1988
- Decision Date
- March 8, 1989
- Product Code
- LCX
- 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 |
|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | FDA class 2 | Clinical Chemistry |
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Other Clearances by Healthcheck Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K874818 | TENSTAR | Sep 28, 1988 | Substantially Equivalent |
| K881003 | DIGITAL BLOOD PRESSURE MONITOR MODEL CX-1 | May 18, 1988 | Substantially Equivalent |
| K863181 | HEALTHCHECK THERM-STRIP | Sep 11, 1986 | Substantially Equivalent |
| K861946 | PTK PLUS. HOME PREGNANCY TEST | Jun 16, 1986 | Substantially Equivalent |
| K860287 | PULSONIC DIGITAL BLOOD PRESSURE MONITOR MODEL BP-3 | Apr 28, 1986 | Substantially Equivalent |
| K851379 | HEALTHCHECK DIGITAL THERMOMETER MODEL 1 TH-2 | Apr 12, 1985 | Substantially Equivalent |
| K850070 | HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2 | Jan 22, 1985 | Substantially Equivalent |
| K844281 | PTK HEALTHCHECK PREGNANCY TEST KIT | Dec 10, 1984 | Substantially Equivalent |