FDA 510(k)
Substantially Equivalent
🇺🇸 United States
LDH PROCEDURE
K Number: K781323
·
Decision Aug 31, 1978
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
12
Review Days
31
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Basic Information
- Device Name
- LDH PROCEDURE
- K Number
- K781323
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Analytical & Research Chemicals, Inc.
- Date Received
- July 31, 1978
- Decision Date
- August 31, 1978
- Advisory Committee
- Unknown
- Review Advisory Committee
- CH
- Third Party
- N
Other Clearances by Analytical & Research Chemicals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K823806 | DIRECT CREATININE PROCEDURE | Jan 14, 1983 | Substantially Equivalent |
| K823786 | ALKALINE PHOSPHATASE | Jan 14, 1983 | Substantially Equivalent |
| K823784 | ENZYMATIC CHOLESTEROL (COLORIMETRIC | Jan 14, 1983 | Substantially Equivalent |
| K781441 | BCG ALBUMIN REAGET | Oct 10, 1978 | Substantially Equivalent |
| K781460 | CHLORIDE REAGENT | Oct 10, 1978 | Substantially Equivalent |
| K781307 | GLUCOSE DETERM. KIT | Aug 31, 1978 | Substantially Equivalent |
| K781309 | GOT PROCEDURE | Aug 31, 1978 | Substantially Equivalent |
| K781306 | UREA NITROGEN TEST KIT | Aug 31, 1978 | Substantially Equivalent |
| K781305 | UREA NITROGEN | Aug 31, 1978 | Substantially Equivalent |
| K781308 | GLUCOLOUR | Aug 31, 1978 | Substantially Equivalent |