FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GENETIC SYSTEMS MICROPLATE READER
K Number: K891767
·
Decision Jul 25, 1989
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
12
Review Days
123
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Basic Information
- Device Name
- GENETIC SYSTEMS MICROPLATE READER
- K Number
- K891767
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Genetic Systems Corp.
- Date Received
- March 24, 1989
- Decision Date
- July 25, 1989
- Product Code
- JJQ
- 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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Genetic Systems Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K891765 | GENETIC SYSTEMS PIPETTOR/DILUTOR | May 1, 1989 | Substantially Equivalent |
| K891766 | GENETIC SYSTEMS MICROPLATE STRIP WASHER | May 1, 1989 | Substantially Equivalent |
| K891768 | GENETIC SYSTEMS MICROPLATE WASHER | May 1, 1989 | Substantially Equivalent |
| K890768 | PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT | Mar 21, 1989 | Substantially Equivalent |
| K873564 | GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES | Nov 20, 1987 | Substantially Equivalent |
| K873542 | MICROPLATE AUTO-WASHER (MOTORIZED STAGE) | Sep 23, 1987 | Substantially Equivalent |
| K870176 | GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT | Jul 16, 1987 | Substantially Equivalent |
| K870879 | ALANINE TRANSAMINASE (ALT) TEST KIT | Mar 19, 1987 | Substantially Equivalent |
| K863566 | GSC 1000 | Oct 16, 1986 | Substantially Equivalent |
| K852237 | LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT | Aug 22, 1985 | Substantially Equivalent |