HS-100 HEADSPACE SAMPLING ACCESSORY
FDA 510(k) clearance K831387 · decided 1983-08-24
Clearance details
- K-number
- K831387
- Device name
- HS-100 HEADSPACE SAMPLING ACCESSORY
- Applicant
- The Perkin-Elmer Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-04-28
- Decision date
- 1983-08-24
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- KZQ
- Device class
- 1
- Regulation number
- 862.2250
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 8000 SERIES GAS CHROMATOGRAPHS (K872122) | The Perkin-Elmer Corp. | 1987-06-17 |
| VARIAN 3300 & 3400 GAS CHROMATOGRAPHS (K841891) | Varian Assoc., Inc. | 1984-07-09 |
| GAS CHROMATOGRAPH 5890A (K832962) | Hewlett-Packard Co. | 1983-10-28 |
| SIGMA 300 GAS CHROMATROGRAPH (K830147) | The Perkin-Elmer Corp. | 1983-02-07 |
| SIGMA 2000 GAS CHROMATOGRAPH (K820283) | The Perkin-Elmer Corp. | 1982-02-23 |
| TRACE ANALYTICAL REDUCTION GAS ANALYZ (K820025) | Trace Analytical | 1982-02-15 |
| MODEL 5790 GAS CHROMATOGRAPH (K820071) | Hewlett-Packard Co. | 1982-01-28 |
| VISTA 44 GAS CHROMATOGRAPHY ANALYSIS (K801745) | Varian Assoc., Inc. | 1980-08-20 |
| 5880 SERIES OF GAS CHROMATOGRAPHS (K791138) | Hewlett-Packard Co. | 1979-07-24 |
| DETECTOR, IR, MODEL GC-33 (K770639) | Peokin-Elmer Corp. | 1977-06-24 |
| GAS CHROMOTOGRAPHS, SIGMA 1,2,3,4,&10 (K770025) | The Perkin-Elmer Corp. | 1977-02-16 |
Recalls involving this device
No recalls on record reference this clearance.