FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HMA URIC ACID TEST
K Number: K781004
·
Decision Jul 27, 1978
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
117
Applicant Total
22
Review Days
41
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
- HMA URIC ACID TEST
- K Number
- K781004
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1775
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Hycel, Inc.
- Date Received
- June 16, 1978
- Decision Date
- July 27, 1978
- Product Code
- KNK
- 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 |
|---|---|---|---|
| KNK | Acid, Uric, Uricase (Colorimetric) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNK), ordered by most recent decision date.
URIC ACID MODEL 3P39
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OLYMPUS URIC ACID REAGENT, MODEL OSR6X98
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VITALAB URIC ACID REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Hycel, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K802422 | HYCEL TRIGYCERIDE II TEST | Oct 6, 1980 | Unknown |
| K790335 | HYCEL M | Feb 27, 1979 | Substantially Equivalent |
| K782116 | KETOSTEROID TEST, HYCEL-17 | Jan 26, 1979 | Substantially Equivalent |
| K782176 | HYCEL LDH-INT TEST | Jan 26, 1979 | Substantially Equivalent |
| K782102 | HYCEL COUNTER 211 | Jan 3, 1979 | Substantially Equivalent |
| K782100 | HYCEL COUNTER 333 | Jan 3, 1979 | Substantially Equivalent |
| K782101 | HYCEL COUNTER 222 | Jan 3, 1979 | Substantially Equivalent |
| K780946 | ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER | Jul 27, 1978 | Substantially Equivalent |
| K780464 | LELECTIVE KINETIC SYSTEM-60 | May 3, 1978 | Substantially Equivalent |
| K780262 | DIRECT UREA NITROGEN TEST | Apr 5, 1978 | Substantially Equivalent |