510(k) K812369
- Device
- GUINEA PIG COMPLEMENT VIRUS ANTIBODY
- Applicant
- DUTCHLAND LABORATORIES, INC.
- 510(k) number
- K812369
- Product code
- KTQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-09-08
- Date received
- 1981-08-20
- Regulation
- 866.4100
- Classification name
- Reagent, Complement
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 8010134
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KTQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K890417 | SPQ(TM) ANTIBODY REAGENT SET II FOR C3 | Atlantic Antibodies | 1989-02-17 |
| K812522 | RABBIT COMPLEMENT | Dutchland Laboratories, Inc. | 1981-09-23 |
| K812370 | GUINEA PIG COMPLEMENT REGULAR | Dutchland Laboratories, Inc. | 1981-09-08 |
| K791117 | RABBIT COMPLEMENT | Calbiochem-Behring Corp. | 1979-08-03 |
| K790380 | LOW-TOX-H RABBIT COMPLEMENT | Cederlane Labs , Ltd. | 1979-03-21 |
Legacy Summary#
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FDA Review#
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