FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PTK HEALTHCHECK PREGNANCY TEST KIT
K Number: K844281
·
Decision Dec 10, 1984
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
225
Applicant Total
9
Review Days
35
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PTK HEALTHCHECK PREGNANCY TEST KIT
- K Number
- K844281
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Healthcheck Corp.
- Date Received
- November 5, 1984
- Decision Date
- December 10, 1984
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LCX), ordered by most recent decision date.
MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Shinetell PlusTM Digital Early Pregnancy Test
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream
FDA 510(k)
FDA Class 2
·Clinical Chemistry
iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Healthcheck Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K884489 | C&T PREGNANCY TEST KIT | Mar 8, 1989 | Substantially Equivalent |
| 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 |