FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FASTTAKE ADAPTER, MODEL # P/N 020-072-01
K Number: K983468
·
Decision Dec 17, 1998
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
77
Applicant Total
15
Review Days
77
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
- FASTTAKE ADAPTER, MODEL # P/N 020-072-01
- K Number
- K983468
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2100
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Selfcare, Inc.
- Date Received
- October 1, 1998
- Decision Date
- December 17, 1998
- Product Code
- JQP
- 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 |
|---|---|---|---|
| JQP | Calculator/Data Processing Module, For Clinical Use | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JQP), ordered by most recent decision date.
BIONIME DIABETES MANAGEMENT SYSTEM VI.0
FDA 510(k)
FDA Class 1
·Clinical Chemistry
THE ROBOLITE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PRENVAL I
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MR7000 WITH TIME MANAGER SOFTWARE (TMS)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EXPRESSO CARTRIDGE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Selfcare, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002867 | INVERNESS MEDICAL OVULATION PREDICTOR TEST | Oct 12, 2000 | Substantially Equivalent |
| K002134 | ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM | Aug 7, 2000 | Substantially Equivalent |
| K002049 | INVERNESS MEDICAL EARLY PREGNANCY TEST | Jul 27, 2000 | Substantially Equivalent |
| K001427 | MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | Jun 2, 2000 | Substantially Equivalent |
| K000583 | FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | Mar 17, 2000 | Substantially Equivalent |
| K993632 | FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | Nov 12, 1999 | Substantially Equivalent |
| K991480 | EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP | Sep 17, 1999 | Substantially Equivalent |
| K991466 | EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) | May 25, 1999 | Substantially Equivalent |
| K991386 | EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK) | May 25, 1999 | Substantially Equivalent |
| K990939 | FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | Apr 20, 1999 | Substantially Equivalent |