FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL
K Number: K940272
·
Decision Apr 20, 1994
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
492
Applicant Total
42
Review Days
98
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Basic Information
- Device Name
- ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL
- K Number
- K940272
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Analytical Control Systems, Inc.
- Date Received
- January 12, 1994
- Decision Date
- April 20, 1994
- Product Code
- JJX
- 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 |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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Other Clearances by Analytical Control Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K961892 | SPECKTIN-LA TEST SET | Mar 7, 1997 | Substantially Equivalent |
| K941115 | ACS CARDIO-TROL CONTROL | Jul 20, 1994 | Substantially Equivalent |
| K940397 | ACS O DILVENT PROTEIN DILUTION MATRIX | Mar 11, 1994 | Substantially Equivalent |
| K930477 | ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR | Jun 7, 1993 | Substantially Equivalent |
| K926012 | ACS APCT REAGENT, MODIFIED | Apr 27, 1993 | Substantially Equivalent |
| K925340 | COAGULATION CONTROL CONTAINING HEMOGLOBIN | Mar 23, 1993 | Substantially Equivalent |
| K925906 | NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL | Feb 18, 1993 | Substantially Equivalent |
| K921223 | ACS FREEZE-DRIED APTT REAGENT | Aug 18, 1992 | Substantially Equivalent |
| K921118 | ACS APCT REAGENT | Jul 28, 1992 | Substantially Equivalent |
| K913249 | ACS ULTRA-1 THROMBOPLASTIN | Dec 4, 1991 | Substantially Equivalent |