510(k) K812372
- Device
- GUINEA PIG BLOOD IN ALSEVER'S, CIT., DEF
- Applicant
- DUTCHLAND LABORATORIES, INC.
- 510(k) number
- K812372
- Product code
- LHT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-09-09
- Date received
- 1981-08-20
- Regulation
- 866.3700
- Classification name
- Staphylococcus Aureus Somatic Antigens
- Medical specialty
- Microbiology
- 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#
- 3003750284
- 8010096
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LHT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K874303 | STAPHYLASE TEST | Oxoid U.S.A., Inc. | 1987-11-06 |
| K863025 | SERO-STAT R II STAPHYLOCOCCUS TEST | Scott Laboratories, Inc. | 1986-09-15 |
| K820531 | ENDO-STAPH TEICHOIC ACID ANTIBODY KIT | Meridian Diagnostics, Inc. | 1982-04-14 |
| K820683 | STAPHYLOCOCCUS LATEX AGGLUTINATION KIT | American Scientific Products | 1982-04-14 |
| K820347 | ACCU-STAPH | Carr-Scarborough Microbiologicals, Inc. | 1982-03-04 |
| K812434 | DIAGNOSTIC KITS & KIT COMPONENTS | Diagnostica, Inc. | 1981-09-23 |
| K812367 | GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD) | Dutchland Laboratories, Inc. | 1981-09-09 |
| K812368 | RAT BLOOD IN ALSEVER'S, CITRATED | Dutchland Laboratories, Inc. | 1981-09-09 |
| K812373 | RABBIT BLOOD IN ALSEVER'S, CITR., DEFIBR | Dutchland Laboratories, Inc. | 1981-09-09 |
| K812374 | ADULT CHICKEN BLOOD IN ALSEVER'S, C., D. | Dutchland Laboratories, Inc. | 1981-09-09 |
| K812375 | BABY CHICK BLOOD IN ALSEVER'S | Dutchland Laboratories, Inc. | 1981-09-09 |
| K812376 | SHEEP BLOOD IN ALSEVER'S, CITR., DEFIBR | Dutchland Laboratories, Inc. | 1981-09-09 |
Legacy Summary#
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FDA Review#
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