FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLYMPUS AMYLASE REAGENT
K Number: K923346
·
Decision Oct 2, 1992
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
98
Applicant Total
142
Review Days
94
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
- OLYMPUS AMYLASE REAGENT
- K Number
- K923346
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1070
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Olympus Corp.
- Date Received
- June 30, 1992
- Decision Date
- October 2, 1992
- Product Code
- JFJ
- 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 |
|---|---|---|---|
| JFJ | Catalytic Methods, Amylase | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JFJ), ordered by most recent decision date.
Amylase2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Atellica CH Amylase_2 (AMY_2)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Olympus Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K915402 | EW-10 AND EW-20 | Jun 23, 1995 | Substantially Equivalent for Some Indications |
| K933200 | OLYMPUS PBD STENTS | Apr 5, 1995 | Substantially Equivalent |
| K942338 | OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES | Nov 30, 1994 | Substantially Equivalent |
| K931763 | HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS | Aug 29, 1994 | Substantially Equivalent |
| K934835 | FLOVAL | Jun 21, 1994 | Substantially Equivalent |
| K931764 | HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES | Jun 8, 1994 | Substantially Equivalent |
| K915857 | FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE | Mar 11, 1994 | Substantially Equivalent |
| K931994 | RESECTOSCOPE SHEATH | Feb 17, 1994 | Substantially Equivalent |
| K933992 | OLYMPUS SCLEROTHERAPY BALLOON | Dec 21, 1993 | Substantially Equivalent |
| K934361 | OLYMPUS CREATININE REAGENT | Nov 16, 1993 | Substantially Equivalent |