510(k) K904499
- Device
- NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM)
- Applicant
- ACKRAD LABORATORIES
- 510(k) number
- K904499
- Product code
- KFG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-07-01
- Date received
- 1990-10-01
- Regulation
- 866.3040
- Classification name
- Antiserum, Positive Control, Aspergillus Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- BERNARD ACKERMAN
- Address
- 70 Jackson Dr. Cranford NJ US 07016 07016
FDA Registration Numbers#
- 3037000637
- 1627497
- 3035708936
- 1217183
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KFG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K792686 | ASPERGILLUS SP, ANTISERUM POSITIVE | Meridian Diagnostics, Inc. | 1980-01-17 |
| K792698 | ASPERGILLUS SP, ANTISERUM, POSITIVE | Meridian Diagnostics, Inc. | 1980-01-17 |
| K791386 | ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM | Immuno-Mycologics, Inc. | 1979-08-16 |
| K760835 | ANTI-ASPERGILLUS CONT. SER. (MYCELIAL) | I M, Inc. | 1976-11-01 |
Legacy Summary#
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FDA Review#
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