FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICROTRAK EIA AUTOREADER
K Number: K891270
·
Decision Jun 16, 1989
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
448
Review Days
99
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Basic Information
- Device Name
- MICROTRAK EIA AUTOREADER
- K Number
- K891270
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Syva Co.
- Date Received
- March 9, 1989
- Decision Date
- June 16, 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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| K Number | Device Name | ||
|---|---|---|---|
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| K011947 | EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL | Jul 2, 2001 | Substantially Equivalent |
| K011528 | EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 | Jun 6, 2001 | Substantially Equivalent |
| K011347 | EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 | May 17, 2001 | Substantially Equivalent |
| K993981 | SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL | Feb 1, 2000 | Substantially Equivalent |
| K993980 | SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL | Feb 1, 2000 | Substantially Equivalent |
| K993987 | SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL | Jan 27, 2000 | Substantially Equivalent |
| K993982 | SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL | Jan 27, 2000 | Substantially Equivalent |
| K993988 | SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL | Jan 27, 2000 | Substantially Equivalent |