510(k) K802628
- Device
- Paragon Electrophoresis Lactate Reag.kit
- Applicant
- BECKMAN INSTRUMENTS, INC.
- 510(k) number
- K802628
- Product code
- CFE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-12-11
- Date received
- 1980-10-23
- Regulation
- 862.1445
- Classification name
- Electrophoretic, Lactate Dehydrogenase Isoenzymes
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 8023024
- 1618982
Source Documents#
510(k) summary PDF not indicated by FDA
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| K905861 | ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH | E.I. Dupont DE Nemours & Co., Inc. | 1991-02-06 |
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| K861750 | CK/LD BUFFER (CAT. NO. 5808) | Helena Laboratories | 1986-05-29 |
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