FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STREP-A-CHEK
K Number: K934129
·
Decision Aug 26, 1994
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
243
Applicant Total
13
Review Days
379
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Basic Information
- Device Name
- STREP-A-CHEK
- K Number
- K934129
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- E-Y Laboratories, Inc.
- Date Received
- August 12, 1993
- Decision Date
- August 26, 1994
- Product Code
- JTO
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | FDA class 1 | Microbiology |
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Other Clearances by E-Y Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K934130 | SWABZYME OXIDASE | Sep 14, 1994 | Substantially Equivalent |
| K940162 | GONOCHEK II REAGENT TUBES | Sep 9, 1994 | Substantially Equivalent |
| K940161 | B-LACTAMASE REAGENT TUBES | Sep 9, 1994 | Substantially Equivalent |
| K934125 | GONOCHEK-II, MODIFICATION | Sep 9, 1994 | Substantially Equivalent |
| K940124 | EY-20 REAGENT TUBES | Aug 26, 1994 | Substantially Equivalent |
| K940020 | STREP-A-CHEK(TM) REAGENT STRIPS | Aug 26, 1994 | Substantially Equivalent |
| K844276 | E-COLI-CHEK TUBE | Dec 13, 1984 | Substantially Equivalent |
| K842600 | STREP-A-CHEK | Jul 11, 1984 | Substantially Equivalent |
| K840810 | SWABZYME-OXIDASE | Apr 4, 1984 | Substantially Equivalent |
| K840884 | STREP-A-CHEK TUBE | Mar 23, 1984 | Substantially Equivalent |