FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HYCEL M
K Number: K790335
·
Decision Feb 27, 1979
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
56
Applicant Total
22
Review Days
6
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
- HYCEL M
- K Number
- K790335
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2170
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Hycel, Inc.
- Date Received
- February 21, 1979
- Decision Date
- February 27, 1979
- Product Code
- JJF
- 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 |
|---|---|---|---|
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJF), ordered by most recent decision date.
ETI-MAX 3000
FDA 510(k)
FDA Class 1
·Clinical Chemistry
POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIGHTCYCLER INSTRUMENT VERSION 1.2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ROCHE COBAS TAQMAN ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CARESIDE ANALYZER
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 |
| 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 |
| K781004 | HMA URIC ACID TEST | Jul 27, 1978 | 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 |