FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUICKRATE REACTION RATE ANALYZER
K Number: K780972
·
Decision Aug 14, 1978
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
7
Applicant Total
142
Review Days
63
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Basic Information
- Device Name
- QUICKRATE REACTION RATE ANALYZER
- K Number
- K780972
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2500
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Olympus Corp.
- Date Received
- June 12, 1978
- Decision Date
- August 14, 1978
- Product Code
- JJI
- 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 |
|---|---|---|---|
| JJI | Analyzer, Enzyme, For Clinical Use | FDA class 1 | Clinical Chemistry |
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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 |