FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GLUCOFACTS DATA PRINTER
K Number: K861779
·
Decision Aug 8, 1986
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
77
Applicant Total
158
Review Days
92
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
- GLUCOFACTS DATA PRINTER
- K Number
- K861779
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2100
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Miles Laboratories, Inc.
- Date Received
- May 8, 1986
- Decision Date
- August 8, 1986
- 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
FASTTAKE ADAPTER, MODEL # P/N 020-072-01
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
Other Clearances by Miles Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880605 | LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER | May 26, 1988 | Substantially Equivalent |
| K874909 | MICRO-BUMINTEST REAGENT TABLETS | Apr 28, 1988 | Substantially Equivalent |
| K875079 | MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE | Apr 5, 1988 | Substantially Equivalent |
| K871835 | GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT | Dec 22, 1987 | Substantially Equivalent |
| K872120 | SERALYZER III BLOOD CHEMISTRY ANALYZER | Oct 28, 1987 | Substantially Equivalent |
| K873304 | CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) | Sep 11, 1987 | Substantially Equivalent |
| K872634 | CUTTER PUREFLO PLUS IV FILTER | Aug 4, 1987 | Substantially Equivalent |
| K870214 | MODIFIED SALTEX REAGENT STRIPS | Jun 29, 1987 | Substantially Equivalent |
| K870752 | SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS | Apr 14, 1987 | Substantially Equivalent |
| K865053 | SERA-TEK MICROSOMAL ANTIBODY TEST | Feb 18, 1987 | Substantially Equivalent |